DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE
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Catalog Number BLACKMAX-N-LP |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.However, the assignable root cause could not be determined.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 by (b)(6) that during service and evaluation, it was observed that the motor device had a damaged component - locking components and could not be engaged.It was further determined that the device failed pre-test for temperature, rotational speed and noise verification.It was noted in the service order that the device did not work at all.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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