Model Number N/A |
Device Problems
Fracture (1260); Output Problem (3005)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint #: (b)(4).Medical product:- unknown 4-hole plate catalog #: ni lot: ni.(b)(6).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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2022-00069.
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Event Description
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It was reported that the screw fractured during attempted insertion.The screw hole was left empty and could not be used due to the shaft embedded in the bone which resulted in sub-optimal fixation of a 4 hole plate.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 conducted on the returned screws.The screws both show attempted signs of use including marking on the screw heads.The screw shafts have fractured where shaft meets the screw head.A dimensional analysis cannot be conducted due to the damage to the screw heads.Medical records were not provided.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 available at the time of this report.
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Search Alerts/Recalls
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