SYNTHES GMBH ELECTRIC PEN DRIVE 60,000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.010 |
Device Problem
Vibration (1674)
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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.This device was returned for service.However, did not meet manufacturing specifications during pre-repair assessment.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (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 electric pen drive device experienced vibration.It was further determined that the device received an error at the maintenance station.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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