DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.705 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to premature wear from normal use and servicing.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 determined that motor power of the battery reamer/drill device was too low.It was further determined that the motor speed was too low and the device stopped after some time.It was further determined that the trigger was broken and torn off and the magnetic holder of the trigger was broken.It was further determined that the device failed pretest for check power at the motor with test bench.Min.190 to 250 watts.It was noted in the service order that the device was not working while being used with the battery casing device.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 available, a supplemental medwatch will be submitted accordingly.
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