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 Stops Intermittently (1599)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during testing, it was discovered that the reverse on the battery reamer/drill device engaged intermittently.The event was not related to surgery.There was no patient involvement reported.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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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.Correction: date device returned to manufacturer: the device returned date was inadvertently omitted from the initial report.The date has been updated as 5/29/2018.The actual device was returned for evaluation.The device was evaluated and the reported condition was confirmed.A visual and functional assessment was performed which found that the unit would not run in reverse mode.It was determined that the device failed the output voltage from the electronic control unit (ecu) in forward and reverse mode and functional test ¿forward¿ and ¿reverse¿.The assignable root cause was determined to be due to normal wear.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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