Model Number N/A |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2015 |
Event Type
Injury
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Event Description
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It was reported that patient underwent total hip arthroplasty on (b)(6) 2015.During the procedure, a sterile packaging of a screw was opened and the surgeon attempted to insert it, but was having difficulty.Surgeon removed the screw from the patient and saw that screw was bent.An alternative screw was used to complete the procedure.
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Manufacturer Narrative
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Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
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Manufacturer Narrative
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Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted that the inspected screw threads show evidence of galling which is consistent with a crossed threading.The root cause of the event is likely due to incorrect surgical technique, the screw was not positioned correctly.
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Search Alerts/Recalls
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