Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/04/2020 |
Event Type
Injury
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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.If any further information which would change or alter any conclusions or information, a supplemental report 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 during an initial procedure that the lag screw inserter broke off in the patient.Broken portion of the inserter was not retrieved.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A linked lag screw was returned for evaluation.Visual examination of the returned product the larger diameter end of the inserter is fractured in two places and the all fractured pieces and inserter drive link were not returned.The device has approximately 11 years of field age and it is unknown how many times the device was used.- reported event is not related to a combination of products; therefore a compatibility review is not applicable.- medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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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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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