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
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Concomitant med products and therapy dates: coupling 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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This is report 1 of 2 for the same event.It was reported from india that the battery handpiece device while being used with a coupling device heated and jammed.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 for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available has been disclosed.If additional information were to 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.The device was evaluated and 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 seized mechanics, the handpiece free moving failed, the bearing and gear were found faulty and failed pre-test for check of free moving and history.These failures were found 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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