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Catalog Number 05.001.201 |
Device Problems
Break (1069); Component Missing (2306); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2023 |
Event Type
malfunction
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Event Description
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It was reported from france that after an unspecified surgical procedure it was observed that the top trigger of the handpiece device was broken and depressed, and part of the trigger was missing.This event did not occur during 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 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 this medwatch, a supplemental medwatch report will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi - (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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that part of the trigger was missing was not confirmed.Therefore, an assignable root cause for the reported condition of missing components was not determined.However, during evaluation, it was determined that the device had worn gear, leak tightness test failure, would not hold/secure battery, would not run, would not hold/secure battery, had illegible labeling etch and component damage.It was further determined that the device failed pretest for general condition, markings, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers, check falling out protection and check general function of device.The assignable root cause was determined to be traced to maintenance.
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Search Alerts/Recalls
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