DEPUY SYNTHES PRODUCTS LLC KINCISE AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1000-00-101 |
Device Problems
Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the device was returned for evaluation.During repair, an evaluation was performed and it was determined that one of the reported condition of excessive noise was not confirmed.Confirmed.The assignable root cause was traced to improper maintenance.A device history review was performed, and no non-conformances were detected related to the reported condition.Udi(b)(4).
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Event Description
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It was reported that the motor device did not fire properly and made a noise sounding like it was dead.The user tried multiple charged batteries.During in-house engineering evaluation, it was determined that the device trigger was sticky, the moving parts did not move smoothly, had unintended motion, had difficulty and was unable to move forward and reverse.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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Search Alerts/Recalls
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