|
Catalog Number 530.705 |
Device Problems
Unintended Movement (3026); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.The battery reamer/drill device was evaluated and the reported condition that the device would generate a push-back when it stopped working was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that moving parts of the trigger of the device were not moving smoothly.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
|
|
Event Description
|
It was reported from (b)(6) that during service and evaluation, it was determined that moving parts of the trigger of the battery reamer/drill device were not moving smoothly.It was noted in the service order that the device would generate a push-back when it stopped 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 not reported, 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.
|
|
Search Alerts/Recalls
|
|
|