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); Complete Loss of Power (4015); Excessive Heating (4030)
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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 from (b)(6) that the small battery drive device was generating heat, stopped working by itself and made abnormal noise.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have 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 the initial medwatch, a follow-up medwatch will be filed as appropriate.The reporter¿s complete facility address was not provided.The actual device was returned for evaluation.The device was evaluated and it was determined that the device had heat, low power, sticky trigger, the locking mechanism was stiff/stuck, and the device made unexpected noise.It was further determined that the device failed pretest for check for sticky triggers, check attachment coupling, and check power with test bench.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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