Model Number N/A |
Device Problems
Device Damaged by Another Device (2915); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.".
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Event Description
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It was reported a patient underwent a total shoulder arthroplasty on (b)(6) 2016.During the procedure, the end of the screw driver was stripped, and could not be used.This occurred after the last screw had been implanted.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Wear of the device was noted.A conclusive root cause for the event could not be determined.
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Search Alerts/Recalls
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