MAUDE Adverse Event Report: SMITH & NEPHEW, INC. Q-FIX WITH NEEDLES - MINITAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205695
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Cartilage damage (4833)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopic internal brace construction ankle procedure, after the q-fix anchor was deployed and when removing the implant applicator handle, a metal piece broke off and was left inside the drilled tunnel.An open surgery was used to retrieve the metal piece with tweezers which resulting in cartilage injuries.There was a surgical delay of more than 20 minutes.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference case-(b)(4).H3, h6: 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 alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was received for evaluation.A visual inspection revealed that the housing door on the distal end of the device has detached and was not returned.The metal driver assembly at the distal tip has detached and was not returned.The suture anchor and ultratape suture were not returned.A functional evaluation was performed on the returned device and found the driver can no longer be advanced as the spool cleat is fully extended from the body of the handle and the ratchet is locked.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 clinical evaluation states that four intra-operative photos shows the device use during the surgery; however, it does not aid in determining the root cause.The photo provided shows the extracted metal fragment, along with an image of the implant applicator handle from which the metal tip became detached.The ifu for the q-fix with needles does warn; ¿it is the healthcare professional¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ a definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (an application of unintended inappropriate or excessive force to the device).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: Q-FIX WITH NEEDLES - MINITAPE
• 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: 23279359
• Report Number: 1219602-2025-02548
• Device Sequence Number: 12152471
• Product Code: MBI
• UDI-Device Identifier: 00885556885642
• UDI-Public: 885556885642
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K231376
• 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): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72205695
• Device Lot Number: 2164660
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown