SYNTHES OBERDORF COLIBRI II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Device Inoperable (1663); Defective Device (2588); Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/21/2016 |
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 small battery drive device motor had seized, was jammed, and heavy moving.It was noted that the motor was faulty.It was also noted that the device failed pre-repair diagnostic tests for off/osc/on switch mode function.It was noted in the service order that the device was ¿not working.¿ this event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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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