|
Catalog Number 72205610 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/08/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that after an acl procedure, it was not possible to get the blade out of the quad cutter, the cutter detached from the shaft.There was no patient involvement.
|
|
Manufacturer Narrative
|
H10: internal complaint reference number: (b)(4).
|
|
Manufacturer Narrative
|
H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|
|
Search Alerts/Recalls
|
|
|