DEPUY SYNTHES PRODUCTS LLC KINCISE BROACH-ADAPTER-ANTERIOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1010-01-102 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture is unknown; therefore, udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported that during service and repair/pre-testing, it was observed that the broach adapter device was dented with sharp edges.The event was not related to surgery.There was no patient involvement.There were no reports of 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.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the broach adapter was dented and had sharp edges (cosmetic damage) and appeared to have been dropped which caused some denting to the top of the adapter (user error).Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to user error.A review of the device history record was performed, and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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