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Catalog Number QD11 |
Device Problems
Loose or Intermittent Connection (1371); Component Missing (2306); Defective Device (2588); Detachment of Device or Device Component (2907); Naturally Worn (2988)
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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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Initial reporter¿s phone number: (b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the angle attachment device had missing components - roll pins.It was further determined that the tool was not detachable, bearing was defective, sleeve for coupling was loose (not glued), various parts were worn and screw and tip were loose.It was noted in the service order that no rotation was possible on the device.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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Manufacturer Narrative
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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.It was determined that the device had roll pin missing, defective bearings, loose coupling, screw and tip.The assignable root cause was due to manufacturing and process error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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