Model Number N/A |
Device Problems
Degraded (1153); Material Deformation (2976)
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Patient Problem
No Information (3190)
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Event Date 07/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products- cortical screw catalog#: 850535034 lot#: jh2aj5f, cortical screw catalog#: 850535034 lot#: ke6aj5f.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2017-06785, 0001825034-2017-06786.
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Event Description
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It is reported that during a trauma procedure, while the surgeon was attempting to implant the screw, the product's head stripped.Two additional screws were attempted, and failed in the same manner.The screws were removed from the patient and discarded.A thirty (30) minute delay occurred as an result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Search Alerts/Recalls
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