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Catalog Number 05.001.201 |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2022 |
Event Type
malfunction
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Event Description
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It was reported by germany that during service and evaluation, it was determined that the trigger of the battery handpiece/modular device was sticky.It was further observed that the device was fractured ¿ trigger, the gear was seized, and the moving parts did not move smoothly.It was determined that the device had a component damage.It was further determined that the device failed pretest for general condition, check for mechanical free moving, check for sticky triggers, check roundness of housing and check for wear on housing.It was noted in the service order that the button of the device was broken.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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the sticky trigger, identified during service and evaluation were confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (b)(4).
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Search Alerts/Recalls
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