Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/02/2021 |
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 instrument broke due to wear during surgery.No consequences or impact to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of repeated use (nicked or gouged) and the item is cracked.The dhr was reviewed and no discrepancies relevant to the reported event were found.The device has been in the field for approximately ten years and three months.It is unknown for how many times the device is being used.Based on the information available, root cause can be determined as 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 report 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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