MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM TI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202618
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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 arthroscopy procedure, when the twinfix anchor was placed, it resisted, an attempt was made to remove it but the blue sutures broke.The anchor was removed with pliers.The procedure was successfully completed with a surgical delay greater than 30 minutes using a smith and nephew back up device.The patient's health condition is stable and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).B5 and b7: event description and bone quality updated.
Event or Problem Description
It was reported that during an arthroscopy procedure, when the twinfix anchor was placed , it resisted, an attempt was made to remove it but the blue sutures broke.The anchor was removed with pliers.The procedure was successfully completed with a surgical delay greater than 30 minutes using a smith and nephew back up device used in the original drilled bone hole.The patient's health condition is stable and no further complications were reported.
Additional Manufacturer Narrative
H10.H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The anchor was returned deformed at the proximal threads but not fractured.The insertion device has no visible defects.The four sutures with needles plus a small section of fractured blue suture were returned off the device.The proximal end, of all four sutures, shows evidence of fraying from being in contact with a sharp instrument such as a grasper.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.A review of material specifications found that fiber tenacity, linear density, knot break strength and diameter must be certified.Sutures must be visually inspected for all non-conforming attributes defined in the procedure and according to the acceptance criteria on the part drawing.Each shipment must have a manufacturers certificate of conformance.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 impact event to the device inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• 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: 21462151
• Report Number: 1219602-2025-00446
• Device Sequence Number: 7854938
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 3596010656131
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K100159
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72202618
• Device Lot Number: 2124137
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 07/03/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/04/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2023
• 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
• Patient Sex: Male