MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRABUTTON TIB MED ADJ FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
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 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 acl reconstruction, it was noticed that a ultrabutton tib med adj fixation dev snapped after button was reduced and as the surgeon was extending the operating leg.No fragments were left in the patient, all components were extra-articular and retrieved safely.The graft had to be removed, and buttons removed, then graft was prepared with new buttons.The procedure was performed, after a delay greater than 30 min, using a competitor device an arthrex tightrope abs implant.Additional anesthesia was required as consequence of the surgical prolongation.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection revealed that it was not returned in original packaging.The short braid is thread through the button and has been fractured on one end and frayed but not broken on its other end.The ultrabutton shows contact with a sharp instrument.Bio debris is present.An assessment of material characteristics found that based on the condition of the product material found during visual inspection, additional material testing is not required.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 suture specifications found that the tensile strength requirements are specified and a certificate of conformity is required with each shipment.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include contact with a sharp instrument and use of excesive force.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.

• Brand Name: ULTRABUTTON TIB MED ADJ FIXATION DEV
• 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: 23280274
• Report Number: 1219602-2025-02549
• Device Sequence Number: 20201273
• Product Code: MBI
• UDI-Device Identifier: 00885556817216
• UDI-Public: 885556817216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222971
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 72205601
• Device Lot Number: 2183844
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2025
• 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: 60 YR
• Patient Sex: Male