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 01/18/2019 |
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 during a knee arthroplasty procedure, the instrument tip fractured during screw insertion all the piece were returned.No adverse event or delay was reported.
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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 evaluation of drill pin and screw inserter shows signs of repeated use (nicked or gouged) and it is fractured.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to routine wear and tear after nearly eight years in the field.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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