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Catalog Number 530.705 |
Device Problems
Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported from germany that during service and evaluation, it was determined that the compact air drive device moving parts did not move smoothly trigger.It was further determined that the device failed pretest for trigger did not move smoothly and the upper trigger was blocked.It was noted in the service order that the device had an unspecified malfunction.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2024.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.
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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.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 actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component wear.(b)(4).
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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.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: upon further evaluation of the returned device it was found that the battery reamer device had electrical control unit damage - would not run and sticky trigger.It was also found that the device failed pre-test for check for sticky trigger, check function of the device and check power with the test bench due to component wear.
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Search Alerts/Recalls
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