Model Number N/A |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 hip fracture nailing procedure, the affixus nail was implanted and the set screw would not move at all.There are no adverse events reported as a result of this malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Udi- (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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