Catalog Number 046W0AN00002 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3003853072-2021-00135 through 3003853072-2021-00144.
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Event Description
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It was reported ten blockers stripped intra-operatively.They were removed and replaced to complete the procedure without patient impacts.This is report two of ten for this event.
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Manufacturer Narrative
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Device evaluation: visual inspection revealed that each blocker had stripped threads and screw drives.The threads particularly had heavy material damage.Potential cause a definitive root cause cannot be determined with the information provided.This event could be attributed to off-axis forces applied during use.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Event Description
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It was reported ten blockers stripped intra-operatively.They were removed and replaced to complete the procedure without patient impacts.This is report two of ten for this event.
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Search Alerts/Recalls
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