DEPUY SYNTHES POWER TOOLS COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Premature Discharge of Battery (1057); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and found that the motor seized, was rough running and drew 5 amperes.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to strain/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 small battery drive device motor had seized and was rough running.It was noted in the service order that the device had an unusual battery discharge and the motor drew 5 amperes.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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