MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tendon transfer procedure using the twinfix suture anchor, while making the second knot, the suture broke so the knot was made with the other suture thread remaining stable in the fixation.Then, when closing the patient, a strange noise was heard so the stitches were removed and it was evidenced that the implant suture was broken.The implant was removed with the original handle and proceeded to finish the procedure using a new implant.The procedure was completed with a delay greater than 30min.Patient's health condition is stable and no further complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10, h3, h6: part of the reported device was received for evaluation.There was no relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 suture found that a material certification is required with each lot.A review of the suture setup found sample sizes, inspection methods, testing methods, and acceptance criteria for testing needle to suture attachment.The procedure found that a visual inspection must be performed.One needle attachment from every other complete assembly is tested for attachment strength during production.A review of the anchor specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A visual inspection of the returned device found that it is not in its original packaging.Part of the implantation device was returned with the anchor.The returned items have debris on them.No suture material was returned and the insertion device did not have the suture needle or the needle holders.Based on the condition of the product material found during visual inspection, additional material testing is not required.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided for this complaint will be re-evaluated.The complaint was not confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include excessive force or torsion during use or use of sharp instruments near the device tip.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.

• Brand Name: TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15090721
• Report Number: 1219602-2022-01045
• Device Sequence Number: 4035344
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 03596010532190
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7210707
• Device Catalogue Number: 7210707
• Device Lot Number: 2089219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 07/24/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male