Model Number N/A |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2018 |
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 during a hip surgery, it was noticed that the bits were bent and did not pass through the drill guide when the drill bit was opened to pre-drill for the screw.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).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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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 inspection of the bits confirmed that they are bent.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.The root cause is determined as manufacturing deficiency.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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