DEPUY SYNTHES POWER TOOLS EPD 60000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.010 |
Device Problems
Corroded (1131); Incorrect Or Inadequate Test Results (2456); Defective Device (2588)
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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 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 electric pen drive device was defective.During service and evaluation, it was observed that the device control unit did not function, was severely corroded and only ran forward.It was further determined that the device failed the following pre-tests: check direction of rotation and check function with foot pedal.The event was not reported to have occurred during surgery.There was no patient involvement reported.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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