SYNTHES GMBH SAGITTAL SAW ATTACH/LG FOR TRAUMA RECON; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.224 |
Device Problems
Noise, Audible (3273); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
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 attachment device was evaluated and the reported condition that the device was making an abnormal was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had heat.The assignable root cause of this condition was determined to be traced to component failure due to wear.
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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 attachment device was generating heat, had a worn bearing, and moving parts of the device were not moving smoothly.It was further determined that the device failed pretest for check for free movement.It was noted in the service order that after an unspecified surgical procedure the device was making an abnormal noise.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 2019.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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