DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Partial Blockage (1065); 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).(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 improper maintenance, which is user error/misuse/abuse.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 from (b)(6) that the compact air drive device had an undetermined malfunction.During service and evaluation, it was observed that the compact air drive device motor power was too low.It was also observed that the motor was blocked.It was also observed that the device had a defect and a worn out motor, the gear and gear-shaft, coupling shaft, soft mode switch and bearings were defective.The device failed the following pre-tests: check the power with test bench and check function of soft mode switch (safety system).It was unknown if the event occurred during a surgical procedure.It was unknown if there were any delays to the surgical procedure or if a spare device was available for use.It was unknown if there was 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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