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Catalog Number 05.001.201 |
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 01/01/2023 |
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.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.During repair, an evaluation was performed and it was determined that the moving parts of the trigger not moving smoothly, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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Event Description
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It was reported by japan that during service and evaluation, it was determined that the moving parts of the trigger did not move smoothly on the battery handpiece/modular device.It was further observed that the device had component damage, would not run, was difficult to assemble/disassemble, had a leak tightness test failure and would not hold/secure battery.It was further determined that the device failed pretest for general condition, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers, check roundness of housing, check falling out protection, check fitting of the lid and check general function of device.It was noted in the service order that the device had an undetermined 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 2023.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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