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 10/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint cmp (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.The user facility is foreign; therefore, a facility medwatch report will not be available.(b)(6).
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Event Description
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It was reported a screw fractured upon implantation.The upper half of the broken screw was recovered, but the lower half was embedded in the bone and could not be removed, so it was left in the patient's body at surgeon's discretion.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A visual inspection was carried out on the screw.The screw head shows heavy signs of use.The screw shaft has fractured along the upper screw threads.The lower fractured portion of the screw was retained by the patient and was not available of inspection.The complaint is confirmed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot 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.This report is being submitted to update additional information in section h2, h3, h6 and h10.
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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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