SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had insufficient/low power, had a worn bearing, and was making excessive noise.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.Udi: (b)(4).
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Event Description
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It was reported from the (b)(6) that during service and evaluation, it was determined that the battery handpiece device had insufficient/low power, the speed of the device could not be controlled/changed, was making excessive noise, and had a worn bearing.It was further determined that the device failed pretest for check function of the device and check the power with the power test bench.It was noted in the service order that the device had a defect.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 not reported, however, it was reported that the event occurred in 2021.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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