SYNTHES GMBH AO REAMING ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.210 |
Device Problems
Mechanical Jam (2983); Complete Loss of Power (4015)
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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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Event Description
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It was reported by india that during service and evaluation, it was determined that the ao reaming attachment device was frozen/would not move and had a component damage.It was further determined that the device failed pretest for check for mechanical free movement and check general function in running mode.It was noted in the service order that the device was not working.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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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.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition of the device being frozen/would not move, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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