DEPUY SYNTHES POWER TOOLS PERFORATOR DRIVER W/HUDSON END; DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER
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Catalog Number CSR60 |
Device Problems
Bent (1059); Break (1069); Defective Component (2292)
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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)(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.The assignable root cause was determined to be due to component damage caused by user error / abuse and possibly misuse.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 compact speed reducer device had a damaged component - bent drive shaft.It was noted in the service order that the device did not work, was damaged by falling, the bearing cover and symbol were faulty.This event did not occur during surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.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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The date of manufacture was not available and documented on the initial report.The date of manufacture has been updated to jan 19, 2013.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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