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
Sticking (1597); Incorrect Or Inadequate Test Results (2456); Physical Resistance (2578)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).The 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 unauthorized repair / improper maintenance, which is user error/misuse/abuse.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 from (b)(6) that the on/off button on the small battery drive device was stuck.During service and evaluation, it was found that the mode switch, resistance was too high and that the switch was stuck.It was also noted that the device failed pre-repair diagnostic tests for off/oscillation/on switch mode function in pre-repair diagnostic assessment.It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.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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