SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Noise, Audible (3273); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the small battery drive device had sticky trigger and was making unexpected noise.It was further determined that the device failed pretest for checking for sticky triggers.It was noted in the service order that the device was making abnormal noise.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 2022.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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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 of sticky trigger identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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