DEPUY SYNTHES POWER TOOLS COMPACT SPEED REDUCER, 60:1; DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER
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Catalog Number CSR60 |
Device Problem
Leak/Splash (1354)
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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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Udi: (b)(4).Initial reporter's phone number: (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 in the service order from (b)(6) that the compact speed reducer device had an oil leak.During service and evaluation, it was confirmed that the device had an oil leak.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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