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
Mechanical Problem (1384); Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: the actual device was returned for evaluation with an unspecified malfunction.Reliability engineering evaluated the device and observed that the motor seized and was rough running.Therefore, the reported condition was confirmed.The assignable root cause was determined to be 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 from (b)(6) that the battery device had an unspecified defect.During an in-house engineering evaluation, it was observed that the motor seized and was running.It was not reported if the device was used during surgery or if there was patient involvement.There were no delays in the surgical procedure.A spare device was not available for use.It was not reported if there were any 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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