DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE
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Catalog Number BLACKMAX-N-LP |
Device Problems
Break (1069); Failure to Power Up (1476)
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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 confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or 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 by (b)(6) that during service and evaluation, it was discovered that there was damaged component to the blades on the motor device.It was further determined that the device had too little power.It was further determined during the pre-repair diagnostics assessment that the device failed for initial rotational speed rpm (rotations per minute) and for noise verification.It was noted on the service order that the device had loss of power /inoperative.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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Manufacturer Narrative
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Upon further review of this complaint, it was determined that the date of this report was incorrectly documented as sep 12, 2016.The date of this report was aug 14, 2016.This information has been updated accordingly.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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