Model Number N/A |
Device Problem
Bent (1059)
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Patient Problem
No Code Available (3191)
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Event Date 05/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product has been 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 was reported that the patient underwent a procedure to implant a trochanter nail.During the insertion, the nail bent and needed to be removed from the patient.Another trochanter nail was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the implant was bent at the distal screw hole.The bend was off by 90° with respect to the print caused due to the additional bend.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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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Search Alerts/Recalls
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