MAUDE Adverse Event Report: SMITH & NEPHEW, INC. Q-FIX WITH NEEDLES #0 SUTURE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205691
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/06/2026
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 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 a left ankle arthroscopy, the q-fix anchor was implanted and deployed after bone tunnel prep with q-fix with needle drill as per surgical technique.After unravelling the sutures and removing the q-fix inserted it was found that the metal outer sheath from the distal tip of the inserter had broken off and embedded in the bone.A bigger skin incision was made to allow better visual for the removal of the foreign bodies from the patient, all pieces of foreign bodies were removed and were confirmed fluoroscopically.Some bone was removed from the tunnel entrance while attempting to remove the broke metal tip of the inserter, while doing so it had dilated the tunnel and the implant piece was pulled out with a tug on the sutures.The procedure was completed with a surgical delay of 5 minutes using a backup twinfix ultra into the original drill hole.No voids were left in the patient.No further complications were reported.

• Brand Name: Q-FIX WITH NEEDLES #0 SUTURE
• 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: 24988815
• Report Number: 1219602-2026-01208
• Device Sequence Number: 9535192
• Product Code: MBI
• UDI-Device Identifier: 00885556885635
• UDI-Public: 885556885635
• 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): 06/10/2026

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: 72205691
• Device Lot Number: 2180595
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2025
• 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