DEPUY SYNTHES POWER TOOLS COLIBRI II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Battery Problem (2885); Naturally Worn (2988)
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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)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.(b)(4) evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.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 from netherlands that during service and evaluation, it was discovered that the small battery drive device control unit did not function, the handpiece had a faulty controller and the motor bearings and tool coupling were worn.It was also observed that the device failed the checks for the off/osc/on switch mode at pre-test.The event was not related to surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.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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