DEPUY SYNTHES POWER TOOLS K-WIRE ATTACHMENT FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.037 |
Device Problems
Device Stops Intermittently (1599); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and it was observed that the device would start and stop running - intermittent operation.It was also noted that the device did not function.There fore the reported condition was confirmed.The assignable root cause was determined to be wear from normal use over time.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 that during pre-surgery setup, it was observed that the k-wire attachment for the pen drive device sputters.During an in-house engineering evaluation it was observed that the device did not function and would start and stop running.There were no delays to the planned surgical procedure as a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, 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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Search Alerts/Recalls
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