SYNTHES GMBH SAGITTAL SAW ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 532.021 |
Device Problems
Mechanical Jam (2983); 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 05/24/2021 |
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.During evaluation it was determined that the initial reported condition of the device was making a grinding noise and heating up was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was confirmed that the device jammed/seized.It was further determined that the moving parts of the device did not move smoothly, there was corrosion/rusting/pitting, and foreign substance/debris.The assignable root cause was determined to be due to improper maintenance.(b)(4).
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Event Description
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It was reported that during that during an unspecified veterinary surgical procedure, it was discovered that the sagittal saw attachment device made a loud noise and then became really hot and seized up.It was reported that there was a thirty-minute delay to the surgical procedure and the surgeon had to remove the bone manually.There was no human patient involvement as the device was used in a veterinary procedure.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 report will be submitted accordingly.
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Search Alerts/Recalls
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