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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Udi: (b)(4).Device evaluation: 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 wear from normal use and servicing.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 determined that the bearings of the motor device were damaged and had corrosion.It was determined that the device had excessive noise level-(db).It was further determined that the device failed pretest for noise verification, and initial rotational speed.It was noted in the service order that the device had an undetermined 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 the event was unknown.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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