Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 07/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign- (b)(6).Concomitant medical products-fib anatomic lock rt 3h ste catalog#:856207003 lot#:245720.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It is reported that during a distal fibula plating procedure, the screw couldn't be fixed into the plate, as it continued to rotate.The screw was removed, and the surgeon finished the surgery successfully with an alternative screw.No additional patient consequences were reported.
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Manufacturer Narrative
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Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product noted damaged of the threads on the head of the screw.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information received.
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Search Alerts/Recalls
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