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); 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.The actual device was returned for evaluation.The device was evaluated and it was determined that the reported condition that the device motor made noise was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was confirmed that the device had low power.The assignable root cause was determined to be traced to component failure from normal wear.Udi ¿ (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the compact air drive had an air leak and low power.It was further determined that the device failed pretest for check for air leak and check power with test bench.It was noted in the service order that the motor of the compact air drive device was making noise, became stuck, and had intermittent 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 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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Search Alerts/Recalls
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