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
Incorrect Or Inadequate Test Results (2456); Defective Device (2588); Device Operates Differently Than Expected (2913); Naturally Worn (2988); Output below Specifications (3004)
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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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(b)(4).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 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 from united kingdom that the compact air drive device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the motor power was too low and the device was defective.It was further determined that the motor, gear, gear-shaft, soft mode switch, and the bearings were worn out.It was further determined that the device failed for check function of soft mode switch (safety system) and for check the power with test bench.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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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