DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II (CAD II); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Partial Blockage (1065); Retraction Problem (1536); Incorrect Or Inadequate Test Results (2456); Difficult or Delayed Activation (2577); Power Problem (3010); Noise, Audible (3273)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/22/2016 |
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 confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that the compact air drive device, quick coupling device and the attachment device were not working.During the pre-repair diagnostics assessment, it was determined that the reverse locking mechanism was blocked on the compact air drive device.It was further determined that the compact air drive device failed for check reverse locking mechanism, check for untrue running, check for excessive noise, and check the power with test bench and for check starting behavior.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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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