SYNTHES GMBH RADIOLUCENT-DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.300 |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 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 traced to component failure due to normal wear and improper handling which is user error.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 radiolucent drive device appeared well used and was received with two separated lock pins, the third lock pin was completely missing, the bush showed signs of excessive wear and the slid sleeve of the tool coupling was unscrewed but still engaged to the thread.It was also observed that the lock pins were missing, the tool coupling did not secure the cutter device, the drill could be inserted and would be forced by the device to rotate but would still falling out.It was further determined that the device failed pretest for general condition and the tool coupling assessments.It was noted in the service order that during an open reduction internal fixation for the humeral fracture, the distal screw insertion the tip of did not work.The surgeon could not attach the drill device to the radiolucent drive device.As a result, the surgeon inserted the distal locking screw without using the radiolucent drive.This event did not occur during surgery.There was no patient involvement.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 will be submitted accordingly.
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