DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Occlusion Within Device (1423); Retraction Problem (1536); Protective Measures Problem (3015)
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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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(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.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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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the motor on the compact air drive device was blocked, seized, and rough running.It was further determined that the device failed pre-repair diagnostic tests for air leak, function of the soft mode switch, excessive noise, and the power with test bench.It was noted in the service order "blocked reverse." it was not reported if the event occurred during a surgical procedure.This event did not occur during surgery.There was no patient involvement reported.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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Manufacturer Narrative
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It was reported in the initial medwatch report that the date of this report was aug 15, 2016.As per communication with affiliate the correct date was jul 15, 2016.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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