DEPUY SYNTHES POWER TOOLS 6.5CM ADULT CRANI ATTACHMT; MOTOR, DRILL, ELECTRIC - CRANIOTOME
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Catalog Number CRANI-A |
Device Problems
Break (1069); Detachment Of Device Component (1104); Component Missing (2306); Protective Measures Problem (3015)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Gtin is unavailable as the product was made prior to compliance date; (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.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 bearings on the craniotome device were damaged and had fallen apart.It was further determined that the device had missing balls, cage and warning symbol; and a damaged bracket.The device also failed the following pre-tests: visual assessment (bracket) and cutter insertion (bearings).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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