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); Intermittent Loss of Power (4016)
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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.Reporter's phone number was not provided.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that the small battery drive device was emitting an abnormal noise when in reverse and sometimes the device was unable to work in reverse.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.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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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.H10 additional narrative: the actual device was returned for evaluation.The small battery drive device was evaluated and the reported condition that the device sometimes was unable to work in reverse was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was making an unexpected noise.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.
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Search Alerts/Recalls
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