DEPUY SYNTHES POWER TOOLS COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Break (1069); Mechanical Problem (1384); Physical Resistance (2578); Defective Device (2588); 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).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the motor seized and was rough running.It was further determined that the motor had high resistance and the nose was damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to strain/wear from normal use and servicing.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 by (b)(6) that during service and evaluation, it was observed that the motor on the small battery drive device seized, was rough running and defective.It was further determined that the device had a high resistance and the nose was damaged.This event did not occur during surgery.There was no patient involvement.There were no 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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