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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 05/06/2022 |
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 battery handpiece device had a sticky trigger, leak tightness test failure, would not run, moving parts did not move smoothly and illegible labeling etch.It was further determined that the device failed pretest for marking & labeling, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers and check function of device.It was noted in the service order that the trigger broke when pressed during an unspecified surgical procedure.According to the reporter, a spare was not available so the procedure was completed with the broken device.It was not reported if there were any delays to the surgical procedure.There was patient involvement reported.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 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 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 reported condition was confirmed.The assignable root cause was determined to be traced to maintenance.Udi: (b)(4).
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Search Alerts/Recalls
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