DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE
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Catalog Number BLACKMAX-N-LP |
Device Problems
Partial Blockage (1065); Break (1069)
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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.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 from (b)(6) that during service and evaluation, it was observed that the motor device had a damaged component- blades; and a blocked hose and motor.It was further determined that the device failed the following pre-tests: temperature, sound and rotations per minute (rpm).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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