Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.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 reamer fractured during reaming as part of an initial knee arthroplasty.No further information is available at this time.
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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.Visual examination of the returned product/provided pictures identified light damages such as scratches and nicks.It is confirmed the tip of the product has fractured off and not all the pieces were returned.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to wear and tear from repeated use of the device as it has a field life of approximately 11 years and 11 months.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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