Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded.
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Event Description
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It was reported that during a knee surgery, while using the hex head driver to insert a hex head pin, a part of the pin driver tip broke.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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Reported event was confirmed by review of photographs.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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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The follow-up report is being submitted to relay additional information.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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It was reported that during a knee surgery, while using the hex head driver to insert a hex head pin, a part of the pin driver tip fractured.The fractured piece of the instrument fell into the patient's wound and had to be retrieved.No additional patient consequences were reported.
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Search Alerts/Recalls
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