DEPUY SYNTHES PRODUCTS LLC COLIBRI II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the small battery drive device suddenly stopped working.It was not reported if there were any delays in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the small battery drive device would not run and the motor was damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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