SYNTHES OBERDORF COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
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).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that motor seized and was rough running.It was also noted that the device had no function.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear and strain 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 motor on the small battery drive device seized and was rough running.It was further observed that the device had no function.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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