SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
|
Back to Search Results |
|
Model Number 7210708 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/14/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Event Description
|
It was reported that, during an open rotator cuff repair of the right shoulder, during suture manipulation and tying, two needles of the twinfix ultrabraid anchor fell to the ground, the needles broke off.Surgery was completed without delay, using the same device.Patient current status is healthy.No further complications were reported.
|
|
Manufacturer Narrative
|
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 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
|
|
|