DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE (COLIBRI); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Unintended System Motion (1430); Failure of Device to Self-Test (2937)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/01/2016 |
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.The assignable root cause was determined to be due to 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 was not working.During the pre-repair diagnostics assessment, it was determined that the motor power too was low, the motor stopped intermittently, and the device had a low torque.It was further determined that the device failed for check 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.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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