SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Noise, Audible (3273); Physical Resistance/Sticking (4012); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
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 small battery drive device was evaluated and the reported condition that the device was making an abnormal noise was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had a sticky trigger and would not run.Therefore, the reported condition that the device stopped working was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi (b)(4).
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Event Description
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It was reported from japan that during service and evaluation, it was determined that the small battery drive device had sticky triggers, the upper and lower triggers were caught, the device stopped by itself, moving parts of the trigger of the device did not move smoothly, and the device would not run.It was further determined that the device failed pretest for check for sticky triggers, check the function of the device, and check the power with the power test bench.It was noted in the service order that the device stopped working during surgery and was making abnormal noise.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 2022.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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