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 05/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Concomitant medical products and therapy dates: sagittal saw attachment device, (b)(6) 2019.The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly. 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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This is event 1 of 2 of the same event.It was reported from india that a battery handpiece device and a sagittal saw attachment device were overheating and would not work.It was not reported if the devices were 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.Corrected data: d10: the date returned for evaluation was reported as may 25, 2019 and has been corrected to may 23, 2019.H10: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device mechanics seized, was free moving and the bearings gear and other parts were faulty.The device also failed pretests for check of free moving, check proper function of the triggers and check history.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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