DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/15/2016 |
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 duplicated and confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that the compact air drive device had an undetermined malfunction.During service and evaluation, it was observed that the trigger was blocked, jammed and moved heavy.It was further determined that the device failed the following pre-tests: check reverse locking mechanism, check for air leak and check triggers for fwd/rev mode.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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