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 08/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
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Event Description
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It is reported that the provisionals broke during knee arthroplasty while the surgeon was hammering the device.No adverse events were reported as a result of these malfunctions.Attempts have been made and no additional information is available 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.The complaint sample was evaluated through photographic inspection and the reported event was confirmed.The photographs provided showed that both devices exhibit signs of usage and were fractured.The device history records were reviewed and no discrepancies were identified.The root cause can be attributed to normal wear and tear from repeated use during the instrument's field life.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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