SYNTHES GMBH COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2019 |
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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the trigger of the compact air drive device was sticky, and the device had a component damage.It was further determined that the device failed pretest for check the attachment coupling and check triggers for forward/reverse motion.It was noted in the service order that the device had an undetermined malfunction.It was further reported that there were no delays in the surgical procedure.It was reported that the procedure was completed as intended.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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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