SYNTHES OBERDORF COLIBRI II. SMALL BATTERY DRIVE DEVICE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the small battery drive device was powerless.It was reported that the event occurred during use on a patient.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were 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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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was determined that the coupling tool side seized, jammed and was moving heavy.It was observed that the tool side was defective.It was further determined that the device failed pretest for check the attachment coupling.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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