SYNTHES GMBH COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Mechanical Jam (2983); Output below Specifications (3004); Physical Resistance/Sticking (4012)
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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.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.(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 power was insufficient/low.It was further observed that the device would not reverse and had a component damage.It was further determined that the device failed pretest for general condition, check reverse locking mechanism with oscillating saw attachment ii, check for sticky trigger and check power with power test bench.It was noted in the service order that the motor designed to operate in reverse did not reverse when it was put into operation.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.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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Search Alerts/Recalls
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