Ivan Tornos

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When the QMS quality management system is set up to baffle regulators instead of protect patients it’s probably not a good business plan. Even if you pull off baffling the regulators the fact that you are so careless with patient safety is astonishing. I recall even one manager saying that’s the dumbest idea to remove quality inspection on the implants and rely on certification processes. Especially when you fill well are aware that you processes are not stable and you have a knack for promoting very ethically challenged leadership. Don’t ask me just review the number of legal issues you have had!!!
 












And to finish up for today. I just started working at a supplier of machined product to Zimmer Biomet. This is an area I worked in before I worked at Zimmer Biomet. I can tell you not much has changed. The quality systems that are required by this company are light years ahead of what they do themselves. The goal seems to be to beat up suppliers and let them hold all the risk while they knowingly and intentionally refuse to do the same intelligent quality standards. They continue to build a system that holds front line workers and suppliers accountable even thou the mass majority of the reward for such behavior is held by the company. This is of course to use to pay the fines and regulators and lawyers that keep coming up. There may not be change but you will never be able to change the truth.
 






Michael S Gibson Mascotti said:
And to finish up for today. I just started working at a supplier of machined product to Zimmer Biomet. This is an area I worked in before I worked at Zimmer Biomet. I can tell you not much has changed. The quality systems that are required by this company are light years ahead of what they do themselves. The goal seems to be to beat up suppliers and let them hold all the risk while they knowingly and intentionally refuse to do the same intelligent quality standards. They continue to build a system that holds front line workers and suppliers accountable even thou the mass majority of the reward for such behavior is held by the company. This is of course to use to pay the fines and regulators and lawyers that keep coming up. There may not be change but you will never be able to change the truth.
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Oh boy. Is this the China or Warsaw manufacturing facility? Can’t imagine that many inspectors are volunteering to get on a flight to China.
 












Who knows what’s gonna happen next LMAO? But there was plenty of out of spec product manufactured under the QMS at Zimmer Biomet. Then they received a FDA form 483 for various reasons. Then they knowingly and intentionally continued with some extremely poor manufacturing processes. According to multiple manufacturing team members of recent and currently working there they are still passing out of spec product. There have been managers continuing to push product that is out of spec. And processes that are not stable being used without safeguards to ensure patient safety. And based off of the most recent conference call my hypothesis is that the senior management team on the call is knowingly lying to stockholders. But just a hypothesis.
 






Michael S Gibson Mascotti said:
Who knows what’s gonna happen next LMAO? But there was plenty of out of spec product manufactured under the QMS at Zimmer Biomet. Then they received a FDA form 483 for various reasons. Then they knowingly and intentionally continued with some extremely poor manufacturing processes. According to multiple manufacturing team members of recent and currently working there they are still passing out of spec product. There have been managers continuing to push product that is out of spec. And processes that are not stable being used without safeguards to ensure patient safety. And based off of the most recent conference call my hypothesis is that the senior management team on the call is knowingly lying to stockholders. But just a hypothesis.
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this is coming from someone who hasn’t been inside a Zimmer building in over 5 years….. bitter people that didn’t do the right thing at the time, who knowingly participated in this so called scheme, is now feeling guilty about what they did? You had plenty of time to lawyer up and turn them in, but nope, on a forum now that nobody cares about because they have nowhere else to go after 5 years of burning bridges.
 






This is coming from a person who has spoken to current employees and recent employees. They all have said the same thing that thou there have been minor improvements most of the exact same activity is occurring. I also used chain of command and quality chain of command when I worked there. I also had a number of opportunities to discuss this with Human Resources and so did many others. If the culture of corruption is still in place it doesn’t matter who these employees talk too. I’ve heard they have even used your compliance hotlines and were dismissed. Why don’t you go fact check these statements instead of commenting? Have a blessed day!
 






Michael S Gibson Mascotti said:
This is coming from a person who has spoken to current employees and recent employees. They all have said the same thing that thou there have been minor improvements most of the exact same activity is occurring. I also used chain of command and quality chain of command when I worked there. I also had a number of opportunities to discuss this with Human Resources and so did many others. If the culture of corruption is still in place it doesn’t matter who these employees talk too. I’ve heard they have even used your compliance hotlines and were dismissed. Why don’t you go fact check these statements instead of commenting? Have a blessed day!
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Been gone for 5 years and still on Zimmer forums??? A real ortho knight here, amazing!
 






Understanding that the prove it crowd is gone now that it’s been proven again!! I find it hilarious that the constant behavior of yeah but look what others are doing. The difference is other companies haven’t consistently and internationally skated the regulations and put faulty product into the field. The entire apparatus of paperwork looping to hide severe integrity and compliance issues is astonishing!! To me just make dimensionally correct product how hard is it. Let’s be honest we all know the falsification of documentation happens at every company. But you can’t falsify dimensions in a part they are what they are and it’s not the front lines job to make sure this is correct it’s the companies. If the company accepts poor behavior and repeated violations they should be held accountable! Let’s be more honest .002” or it’s metric equivalent isn’t the same as .02”. Also .02” on a screw driver isn’t the same as .02” on a VPC screw thread thinning the wall leaving the potential for shearing off!!! When this is bad in one order and you don’t go back to the previous orders you know there is a large chance you have sent non conforming product into the field again and it’s a conscious choice!! Again nothing new for this facility!! And it’s continuing why and has continued why? Why lie to stockholders if that’s what is being done?
 






Michael S Gibson Mascotti said:
Understanding that the prove it crowd is gone now that it’s been proven again!! I find it hilarious that the constant behavior of yeah but look what others are doing. The difference is other companies haven’t consistently and internationally skated the regulations and put faulty product into the field. The entire apparatus of paperwork looping to hide severe integrity and compliance issues is astonishing!! To me just make dimensionally correct product how hard is it. Let’s be honest we all know the falsification of documentation happens at every company. But you can’t falsify dimensions in a part they are what they are and it’s not the front lines job to make sure this is correct it’s the companies. If the company accepts poor behavior and repeated violations they should be held accountable! Let’s be more honest .002” or it’s metric equivalent isn’t the same as .02”. Also .02” on a screw driver isn’t the same as .02” on a VPC screw thread thinning the wall leaving the potential for shearing off!!! When this is bad in one order and you don’t go back to the previous orders you know there is a large chance you have sent non conforming product into the field again and it’s a conscious choice!! Again nothing new for this facility!! And it’s continuing why and has continued why? Why lie to stockholders if that’s what is being done?
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1:57AM? Someone clearly has some time on their hands. I actually feel sorry you, man.
 






anonymous said:
1:57AM? Someone clearly has some time on their hands. I actually feel sorry you, man.
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Aww shucks thank you. I absolutely do have time on my hands. I also am not going anywhere and will be here there and everywhere ensuring this terrible lack of sympathy for patient safety is at least heard. Even if it’s on this troll site no one pays any attention too. It you could find it in your heart please feel a little sorry for those who have taken the unnecessary risk and been implanted with product that is excessively out of print. They may have complications and there is the possibility of damages and when root cause analysis is done let’s be honest about the incredible lack of quality. Also the complete disregard for patient safety.
 






This the same guy that gave his name then when you google it DV charges come up? Sounds like his life is falling apart and clinging on to this moment in his timeline as the reason why.
 


















Come after my character hahahaha it’s all that is left when the facts are out. This isn’t a new tactic I believe Zimmer Biomet has done this before. Still here still standing and I will still be vocal until I get muzzled!! It is apparent that this company is who it is and has done the things it has done. I am just speaking to the facts!! From a quality standpoint I worked in building 5 after the FDA tried to get this company to appreciate patient safety. I was ther in 2011 into 2012. They failed but improved. I then saw as they continued to disregard when after the merger with Biomet. This company tries to play the victim. But they took a bad situation and made it much much worse. For example Biomet at least had floor inspection and inspection operations to guardrail their complete lack of process control. Then Zimmer Biomet leadership post merger removed the guardrails which coupled with lack of process control. This allowed for a the extreme to happen.
 






I was then there when the FDA returned and inspected finding willful and intentional disregard for patient safety again and issued the form 483 later that year. Now as stated above it appears they have returned to old habits!! What happens next who knows??? Maybe they skate by maybe they are held accountable I sure don’t know I’m just getting the info out!!
 






This is not new information. While I worked in this facility the management passed parts out of spec dims as much as .125”. One example is on a Lag Screw. Another example is on trauma plates. There are so many and this was communicated to HR, Management, Quality management and lots of really good people tried to stop this. Now they have made some progress I’m sure but these are facts and I will assume there is much more. Current and recent employees say not much has changed. Hit me if you like again just speaking facts. I would watch out for VPC screws as I seen very thin walled product out of spec not get sorted back to the start of non conformance. If you’re asking yourself how this has continued I’m sure the directors of the company are being honest !!! That was sarcasm just more honesty hahahaha
 






Ask nice ask twice then burn you to the ground!! You could have gave this up. You could have just done the right thing! It’s not difficult. Do what’s right not what’s profitable and the money is easy in ortho. Why? Why Ivan? What’s the motivation? Why Zimmer Biomet? Why after all the legal trouble and issues why? Asking for a friend!!
 












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