DEPUY SYNTHES POWER TOOLS QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.022 |
Device Problem
Unstable (1667)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The manufacturing location was unknown.(b)(6).Device manufacture date: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported from (b)(6) that the quick coupling device was wobbling.It is unknown if the event occurred during a surgical procedure.It was reported that the device was being used for a veterinary procedure.It was reported that there was no delay in a scheduled surgical procedure due to the event.It was not reported if a spare device was available for use.There was no patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the device wobbling was confirmed.An assessment was performed on the device and it was found that the coupling tool side was worn out, and the clamps and bearings were worn.It was further noted that the attachment had worn out grip fingers and bearings.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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