DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Contamination (1120); Mechanical Problem (1384); Physical Resistance (2578); Charging Problem (2892); Mechanical Jam (2983); Naturally Worn (2988); Noise, Audible (3273)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the motor seized and rough running.It was further determined that the machine was heavily contaminated, motor defective (draws too much charging current 0.86amps), coupling head worn, and made strange noises.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to faulty cleaning and maintenance.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 by (b)(6) that during service and evaluation, it was observed that the motor seized and rough running on the small battery drive device.It was further observed the machine was heavily contaminated ,motor defective (draws too much charging current 0.86amps),coupling head worn, and made strange noises.This event did not occur during surgery.There was no 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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