Model Number N/A |
Device Problem
Crack (1135)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Event Description
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It was reported that the impactors had hair line cracks in them.This was discovered in the warehouse and no patient injuries or delays in procedure were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Updated: it was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no trends were identified.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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