DEPUY SYNTHES PRODUCTS LLC KINCISE PINNACLE SHELL/LINER IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1011-01-101 |
Device Problems
Break (1069); Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation. quality engineering evaluated the device and it was determined that the damaged threads was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the device operated as intended; however, the terminal threads were corroded.It was further determined that the device failed pretest for visual assessment.Therefore, the reported condition of corrosion/rusting/pitting was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (b)(4).
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Event Description
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It was reported that during an unspecified surgical procedure, it was observed that the threads of the shell/liner impactor device were damaged.During in-house engineering evaluation, it was observed that the terminal threads were corroded.It was reported that there was less than a thirty-minute delay in the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.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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Search Alerts/Recalls
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