DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE (COLIBRI); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Incorrect Or Inadequate Test Results (2456); Physical Resistance (2578); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)
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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.Reliability engineering evaluated the device and the reported condition was confirmed.It was further determined that the motor was running rough and was defective.The assignable root cause was determined to be due to premature wear from normal use and servicing.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 the small battery drive device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the motor seized, jammed and was moving heavy.It was further determined that the motor had interruption.It was further determined that the device failed for checks for the off/osc/on switch mode function.This event did not occur during surgery.There was no patient involvement.There were no reports of 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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