DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.201 |
Device Problems
Overheating of Device (1437); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2019 |
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 submitted accordingly.
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Event Description
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It was reported from (b)(6) that the battery handpiece/modular device was heating up and making a loud sound.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.The exact date of the event was unknown.However, it was reported that the event occurred in 2019.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 reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the mechanics seized, and the bearings were worn.It was further determined that the device failed pretest for check of free moving.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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Search Alerts/Recalls
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