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 Problems
Unintended System Motion (1430); Fail-Safe Did Not Operate (4046)
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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 the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.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 pen drive device ran in the locked position, had unintended activation/motion and insufficient/low power.It was further determined that the device failed pretest for check for unintended motion, check function in "lock" mode with the pen drive hand switch, function in "lock" mode with the foot pedal and check speed with the tachometer.It was noted in the service order that the device had an unspecified malfunction.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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