SMITH & NEPHEW, INC. TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
|
Back to Search Results |
|
Model Number 72202626 |
Device Problem
Break (1069)
|
Patient Problem
Rupture (2208)
|
Event Date 11/14/2022 |
Event Type
Injury
|
Event Description
|
It was reported that during an arthroscopy, where a golden awl was used to prepare the insertion site, two (2) twinfix ultra anchors got broken while being inserted into the bone, event after proper procedure was followed by the surgeon.All the broken pieces were retrieved from the patient, easily using forceps.Surgery resumed after a non-significant delay with a back-up device in an additional drilled bone hole, however no voids were left in the patient.No further complications were reported.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
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 similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with the provided percentage composition specifications as measured by ash test.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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
|
|
|