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); Corroded (1131); Material Discolored (1170); Retraction Problem (1536); Incorrect Or Inadequate Test Results (2456); Connection Problem (2900); Mechanical Jam (2983); Power Problem (3010); Noise, Audible (3273)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/24/2016 |
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 during service and evaluation, it was discovered that the motor power was too low on the compact air drive device.It was further determined that the trigger / slider was blocked, jammed and was moving heavy.It was observed that the device had lack of power, corroded and was rusted.It was further determined during the pre-repair diagnostics assessment that the device failed for check the attachment coupling, check attachment coupling with attachments, check reverse locking mechanism, check function of soft mode switch (safety system), check triggers for forward/reverse mode, check for untrue running, check for excessive noise, check the power with test bench and for check starting behavior.It was noted on the service order that the trigger was blocked.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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