MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FST FIX FLX REV CRVD INSRTR BNDR CANN ST; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72205325
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/22/2026
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 an arthroscopy with meniscal repair, after the t implants of one (1) fast-fix flex were deployed.During suture tightening, there was unexpected resistance while advancing the suture.A knot pusher was used to achieve the tension, but the suture snapped.Due to the suture failure, the device was deemed non-functional for completion of the repair.The implanted anchor from the initial device remained in situ.Both ts were secure but unable to tighten properly.All t implants were left secure in the patient.The procedure was resumed, after a non-significant delay, using an equivalent s+n back-up.Additional anesthesia was not required as consequence of the surgical prolongation.No further complications were reported.

• Brand Name: FST FIX FLX REV CRVD INSRTR BNDR CANN ST
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 25149249
• Report Number: 1219602-2026-01410
• Device Sequence Number: 10745643
• Product Code: GAT
• UDI-Device Identifier: 00885556780800
• UDI-Public: 885556780800
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K203393
• 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
• Report Date (Section B): 05/12/2026

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: 72205325
• Device Lot Number: 2193095
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 10/02/2025
• 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: 54 YR
• Patient Sex: Female