DEPUY SYNTHES POWER TOOLS COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that during an unspecified surgical procedure small battery drive device was working on and off.There was no delay to a surgical procedure.A spare device was used to complete the procedure successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device motor seized, jammed, moved heavy and the device did not function.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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