MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72200752
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an unknown procedure, the twinfix suture in the patient's body broke.The procedure was successfully completed using a smith and nephew back up device.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H10: b1, b2, b5.E1, e2, e3, g2, h1, h6: event description, contact information and clinical and impact codes updated.
Event or Problem Description
It was reported that during an unknown procedure, the twinfix suture in the patient's body broke.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.Not all pieces were removed from the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10: h3, h6: part of the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned with the distal tip fractured off and not returned, no suture or implants were returned.There is biological debris on the returned device.Based on the condition of the product material found during visual inspection, additional material testing is not required.An analysis of the customer provided image found the device laying over a box.The whole device cannot be seen, only the handle and the shaft.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.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.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 review of the suture material specifications found a material certification of analysis is required with each lot.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (excessive force or torsion during use).Based on this investigation, there is no evidence to suggest a design, material, or manufacturing issue.Therefore, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during an arthroscopy procedure, the twinfix suture in the patient's body broke.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.Not all pieces were removed from the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).

• Brand Name: TWINFIX TI 3.5 ULTRABRAID
• 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: 20710212
• Report Number: 1219602-2024-02554
• Device Sequence Number: 8212046
• Product Code: MBI
• UDI-Device Identifier: 03596010578921
• UDI-Public: 3596010578921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2025

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 Catalogue Number: 72200752
• Device Lot Number: 2100425
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided; 03/04/2025; 03/04/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 11/28/2024; 03/05/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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: Other
• Patient Sex: Unknown