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

Catalog Number	72205884
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/26/2026
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 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.
Event or Problem Description
It was reported that during a mpfl open surgery, a 1.8 mm straight drill was used to prepare the bone for implantation.One (1) q-fix 1.8 mm anchor was then inserted into the drill sleeve and deployed normally.The minitape was then placed into the cobraid black loop to be shuttled across the implant, and the end of the minitape was visible exiting the implant.The surgeon continued to tug on the minitape tail to reduce the loop, however, the tail snapped midway, and upon removal of the tape, the part that was supposed to enter the implant could be seen to be crumbled, causing it to be too thick to be shuttled into the implant.The procedure was completed, after a non-significant delay, with an equivalent s+n back up product.The surgeon used a 2.3mm bioraptor pk with a 2.3 mm drill into a new hole, and the remaining q-fix 1.8 anchor is still in patient's bone, the minitape excess was cut.No patient information available.No void left.No patient harm or injury.Additional anesthesia was not required as consequence of the surgical prolongation.No further complications were reported.

• Brand Name: Q-FIX KNTLS ASA 1.8MM W/1 MT SUT 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: 24410355
• Report Number: 1219602-2026-00543
• Device Sequence Number: 5917467
• Product Code: MBI
• UDI-Device Identifier: 00885556901700
• UDI-Public: 885556901700
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2026

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: 72205884
• Device Lot Number: 2186500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/21/2026
• Date Device Manufactured: 07/08/2025
• 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 Sex: Unknown