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	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl fixation, upon tensioning the tibial ultrabutton fixation device, all the sutures broke from the button, causing the fixation to fail.The graft was removed, and preparation was undertaken a second time.The second ultrabutton fixation device failed in the same way as the first.The graft had to be removed again, and the preparation undertaken for a third time.On this occasion, an alternative lot number was used, and the implant worked as expected.An intra-op delay of 1 hour was reported.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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.
Additional Manufacturer Narrative
H10 h3, h6: the reported devices were received for evaluation.A visual inspection revealed two ultrabuttons and one partial braided adjustable suture assembly were returned in original packaging with the batch number of the complaint on the label.One half of the suture assembly is still threaded through two of the holes on one ultrabutton.The suture shows fraying at the holes of the button.There are abrasion marks on the button from 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 the material specification found that the requirements for the material and the material must comply with provided certificate of conformance.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include excessive force or contact with a sharp grasper/instrument.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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11: a3: updated.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.

• 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: 22900996
• Report Number: 1219602-2025-02112
• Device Sequence Number: 9089350
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2025

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: 72205601
• Device Lot Number: 2183045
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 10/25/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2025
• 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: A
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 70 KG