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
Unexpected Shutdown (4019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Concomitant med products and therapy dates: battery device (b)(6) 2019.The reporter¿s phone number was not provided.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 submitted accordingly.
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Event Description
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It was reported from (b)(6) that suddenly inside the ¿ot¿ the battery reamer/drill device stopped working.It was further reported that the device was checked using an extra battery device; however, it did not work.It was reported that the button was also not working properly.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the device would not run, and the motor was damaged.It was further determined that the device failed pretest for functional test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to component failure (faulty parts) , which is normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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