Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).The product will not be returned to zimmer biomet for investigation.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 procedure, the cortical screw fractured.It was noted that the stem of the screw remains implanted inside the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs received.Visual examination of the provided picture identified the head of the screw fractured and the rest of the screw is not visible.The device history record (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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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