DEPUY SYNTHES PRODUCTS LLC BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE
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Catalog Number BLACKMAX-N-LP |
Device Problems
Output below Specifications (3004); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the motor device had damaged and corroded bearings, excessive noise level, damaged blades and rotations per minute below specification.It was further determined that the device failed pretest for noise and rotational speed.It was noted in the service order that the device had an unspecified malfunction.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 will be submitted accordingly.
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Search Alerts/Recalls
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