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

Catalog Number	72205883
Medical Device Problem Codes	Failure to Cycle (1142); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/28/2025
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 alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an arthroscopic anatomic glenoid reconstruction the surgeon successfully deployed the 1.8mm q-fix knotless anchor.The repair suture was successfully passed around labrum and shuttled through the all-suture anchor per-standard procedure.When tensioning the repair suture around the labrum, the repair suture became stuck, and the surgeon was unable to fully reduce the sutures preventing a proper labral repair.A new hole was drilled as the anchor remained fixed in the glenoid.The surgeon elected to cut repair suture of the q-fix knotless device, leaving just the anchor.He then drilled and implanted a 1.8mm q-fix in close proximity to the q-fix knotless anchor.There was no void, the implanted suture ball was left in the patient.The instruments to prepare the insertion site were q-fix all-suture anchor twist drill, 1.8mm, in conjunction with q-fix all-suture anchor drill guide xl, crown tip, 1.8mm, nonsterile, reusable sterile, disposable.Insertion site was prepared in a routine manner; the drill was cycled.The procedure was resumed, with a non-significant delay, using a similar sn back-up.The patient was not exposed to additional anesthesia no further complications were reported.
Additional Manufacturer Narrative
H11: h2: additional information in b5.
Event or Problem Description
It was reported that during an arthroscopic anatomic glenoid reconstruction the surgeon successfully deployed the 1.8mm q-fix knotless anchor.The repair suture was successfully passed around labrum and shuttled through the all-suture anchor per-standard procedure.When tensioning the repair suture around the labrum, the repair suture became stuck, and the surgeon was unable to fully reduce the sutures preventing a proper labral repair.A new hole was drilled as the anchor remained fixed in the glenoid.The surgeon elected to cut repair suture of the q-fix knotless device, leaving just the anchor.He then drilled and implanted a 1.8mm q-fix in close proximity to the q-fix knotless anchor.There was no void, the implanted suture ball was left in the patient.The instruments to prepare the insertion site were q-fix all-suture anchor twist drill, 1.8mm, in conjunction with q-fix all-suture anchor drill guide xl, crown tip, 1.8mm, nonsterile, reusable sterile, disposable.Insertion site was prepared in a routine manner; the drill was cycled.The procedure was resumed, with a non-significant delay, using a similar sn back-up.The patient was not exposed to additional anesthesia.The current status of the patient is well.No further complications were reported.

• Brand Name: Q-FIX KNTLS ASA 1.8MM W/1 UB 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: 23613341
• Report Number: 1219602-2025-02953
• Device Sequence Number: 10037666
• Product Code: MBI
• UDI-Device Identifier: 00885556901694
• UDI-Public: 885556901694
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 72205883
• Device Lot Number: 2174140
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2025
• 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: 21 YR
• Patient Sex: Male