DEPUY SYNTHES POWER TOOLS K-WIRE ATTACHM F/EPD+APD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.037 |
Device Problems
Degraded (1153); Device Operates Differently Than Expected (2913); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.(b)(4) evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the attachment device had general wear with adaptor and internal and external components.It was also noted that the device failed pre-test for physical condition of the equipment, needle grip system and unintended oscillations.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.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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