DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.201 |
Device Problem
Excessive Heating (4030)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Concomitant med products and therapy date: lid device and battery device, (b)(6) 2019.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 finland that the battery handpiece device while being used with a lid device and battery device became heated.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 the surgical procedure, or if a spare device was available for use.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 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 it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device had a deformed/bent housing, worn bearing and failed pre-test for check response of the on/off trigger, check for roundness, check of free moving and check for leakage.The assignable root cause was determined to be traced to component failure due to 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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