DEPUY SYNTHES POWER TOOLS 6.5CM ADULT CRANI ATTACHMT; MOTOR, DRILL, ELECTRIC - CRANIOTOME
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Catalog Number CRANI-A |
Device Problems
Peeled/Delaminated (1454); Vibration (1674); Naturally Worn (2988); Noise, Audible (3273)
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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.The assignable root cause was determined to be due to wear from normal use and servicing over time.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 the bearings in the cranitome device had been dropped; and that it was hard to insert the cutter devices.It was also observed that the guard of dura mater peeled off and the device made an abnormal noise and was vibrating.During service and evaluation, it was observed that the bearings were worn.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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