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

Catalog Number	72205859
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165); Joint Laxity (4526)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision mpfl reconstruction procedure, it was noticed that two (2) q-fix anchor remained in-site after it was deployed, but the loaded minitape suture tails were severed in half once inserter and guide were removed.The sutures were removed from patient.The procedure was resumed after a non-significant delay, using a similar s+n back up product on an additional drilled bone hole, leaving a void in the patient.Patient is healthy and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H11: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 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.
Additional Manufacturer Narrative
Additional information: b5: describe event or problem, b7: other relevant history, including preexisting medical conditions and h6: health effect - clinical code.
Event or Problem Description
It was reported that during a revision mpfl reconstruction procedure, it was noticed that two (2) q-fix anchor remained in-site after it was deployed, but the loaded minitape suture tails were severed in half once inserter and guide were removed.The sutures were removed from patient.The procedure was resumed after a non-significant delay, using a similar s+n back up product on an additional drilled bone hole, leaving a void in the patient.Patient is healthy however it was reported that presented instability.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: additional information on: b7.Corrected information on: h6 (clinical code and impact code).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 no 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 specifications found that a certificate of conformance is required with each shipment.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.

• Brand Name: 1.8MM Q-FIX ASA W/1 MT 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: 24394942
• Report Number: 1219602-2026-00524
• Device Sequence Number: 8569732
• Product Code: MBI
• UDI-Device Identifier: 00885556885390
• UDI-Public: 885556885390
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133727
• 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,Followup,Followup
• Report Date (Section B): 06/09/2026

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: 72205859
• Device Lot Number: 2167286
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 03/20/2026; 06/05/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 02/25/2026; 03/25/2026; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2024
• 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: 13 YR
• Patient Sex: Female