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
Intermittent Loss of Power (4016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had intermittent power.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi ¿ (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery reamer/drill device had intermittent operation and insufficient/low power.It was further determined that the device failed pretest for check power at the motor with test bench.It was noted in the service order that the device did not work anymore.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 the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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