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Catalog Number 05.001.201 |
Device Problems
Device Slipped (1584); 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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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.The actual device was returned for evaluation.The handpiece device was evaluated and the reported condition that the lid of the device could e removed while in the locking position was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had a sticky trigger.The assignable root cause of this condition 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 from germany that during service and evaluation, it was determined that the battery handpiece device failed the leak tightness test, had a sticky trigger, and would not run.It was further determined that the device failed pretest for general condition, leakage test using bubble emission technique, check for mechanical free movement, check for sticky triggers, and check general function of the device.It was noted in the service order that the lid of the device can be removed while in the locking position.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 not reported, however, it was reported that the event occurred in 2024.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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