MAUDE Adverse Event Report: SMITH & NEPHEW, INC. Q-FIX KNTLS ASA 1.8MM W/1 MT SUT CB-BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205885
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder instability procedure, it was noticed that three (3) q fix anchors failed.The first q fix anchor was successfully deployed, but the suture broke as it appeared to be frayed when surgeon flossed the transfer suture (case (b)(4).The second q-fix anchor could not be deployed from the inserter (case (b)(4) and when placing the third and final anchor it was deployed successfully, but when flossing the suture, it broke again (case (b)(4).The remaining sutures were stripped by pulling them and the repair sutures were cut with a suture cutter.The procedure was resumed without any delay, using an equivalent s+n back up product on the original drilled bone holes, leaving no void in the patient.Patient outcome is normal and no further complications were reported.
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 risks with the device itself or with its use 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 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: Q-FIX KNTLS ASA 1.8MM W/1 MT SUT CB-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: 24322324
• Report Number: 1219602-2026-00459
• Device Sequence Number: 18624637
• Product Code: MBI
• UDI-Device Identifier: 00885556901717
• UDI-Public: 885556901717
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K241435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 72205885
• Device Lot Number: 2185304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 06/11/2025
• 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: 38 YR
• Patient Sex: Female