DEPUY SYNTHES POWER TOOLS COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Power Conditioning Problem (1474); 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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(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device motor seized, jammed and was heavy moving.It was further reported that the motor had enough power, but was overheating and the ball bearings were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.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 use, it was observed the rotational speed was lower than expected on the small battery drive device.During in-house engineering evaluation, it was observed that the device motor seized, jammed and was heavy moving.It was further reported that the motor had enough power but was overheating and the ball bearings were worn.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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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