MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202595
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during knee lcl repair surgery, the anchor was noted to have fractured during insertion.The procedure was resumed, without any delay, using an equivalent sn back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected and additional information in b5 and h6: health effect - impact code.
Event or Problem Description
It was reported that during knee lcl repair surgery, the anchor was noted to have fractured during insertion.The fragment was removed with tweezers.The procedure was resumed, without any delay, using an equivalent sn back-up on the originally drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
H11: h3, h6: part of the device, used in treatment, 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 sutures are still on the device and run through the cannula but have been cut at the distal tip of the device.The distal tip of the device is bent.The anchor was not returned.Bio debris is present.A material assessment could not be performed due to the part not being returned for evaluation.An evaluation of the customer provided images showed the device packed inside a plastic glove.No anchor is visible.The third image showed the label with the corresponding reported information.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 the material specifications found that the storage conditions and material requirements are specified for the implant material.Each lot must be accompanied by a material certificate of analysis.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24498761
• Report Number: 1219602-2026-00693
• Device Sequence Number: 9960658
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 3596010647467
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 72202595
• Device Lot Number: 2128998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 05/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/13/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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 Age: 38 YR
• Patient Sex: Male
• Patient Weight: 69 KG