SYNTHES GMBH COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Noise, Audible (3273); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2022 |
Event Type
malfunction
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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 device moving parts did not move smoothly, the mode switch resistance was low, made excessive nose, had low power and had an air leak.It was further determined that the device failed pretests for free movement of soft mode switch, noticeable noise, power with power test bench and air leak.It was noted in the service order that the device did no work.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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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.An evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.Udi: (b)(4).
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Search Alerts/Recalls
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