DEPUY SYNTHES POWER TOOLS EPD 60000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.010 |
Device Problems
Moisture Damage (1405); Device Inoperable (1663); Failure to Shut Off (2939)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/03/2016 |
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 electric pen drive device was not working.During the pre-repair diagnostics assessment, it was determined that the device ran by itself.It was determined that the electronic control unit (ecu) was faulty and water stains were found on the motor surface.It was further determined that the device failed for check function and direction of rotation, check function with test hand switch, check function with foot pedal and for check with test hand switch.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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