DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II (CAD II); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Vibration (1674); Defective Device (2588)
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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).This 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.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 discovered that the motor seized, was running rough and defective on the compact air drive device.It was further determined that the bearings and soft mode switch were worn out.It was further determined during the pre-repair diagnostics assessment that the device failed for check function of soft mode switch (safety system), check for untrue running, check for excessive noise and for check starting behavior.It was noted on the service order that the device had vibration during use.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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