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 Energy Output (4025)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 during an unspecified surgical procedure, it was observed that the battery reamer device would sometimes not start and was not moving properly.It was reported that there was an unknown amount of surgical delay.It was not reported if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.During evaluation of the device, it was determined that the device had a worn bearing.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to component failure due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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