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 02/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It is reported that during a procedure, the screw fractured during insertion with a fragment being retained by the patient.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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This follow-up report is being submitted to relay additional information.No product was returned.A visual inspection was conducted on the customer provided picture.The picture shows a clear fracture on the screw shaft.The screw head shows scratching as well.The complaint is confirmed.A determination cannot be made as to what caused the screw to fracture off of the customer provided picture.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 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 is available at the time of this report.
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Search Alerts/Recalls
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