Model Number N/A |
Device Problems
Difficult to Remove (1528); Separation Failure (2547)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 06/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04590, 0001825034 - 2018 - 04589.Not returned to manufacturer.
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Event Description
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It was reported that during a revision elbow arthroplasty, following trialing of the components, the surgeon tried to remove a lock screw with a driver but the screw did not release despite trying repeatedly.Eventually, the ulnar trial and humeral trial were forcibly pulled in greater flexion position, which resulted in the patient's bone fracturing.The fracture was fixed with a wire and the procedure was successfully completed.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of product returned.Per visual inspection, the product is at least 8 years old and shows severe signs of wear.It is confirmed that the one screw that is installed does not come out of the instrument.Dhr was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A summary of the investigation has been sent to the complainant.Investigation and root cause remained unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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