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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 risks with the device itself or with its use 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.
Event or Problem Description
It was reported that, during 3-4 procedures, the suture of the fast-fix flex devices broke off while tensioning the knot down.The residual suture was removed with a shaver.It is unknown the exact number of patients who experienced this issue or the outcomes for the patients involved.No additional information was provided.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, the suture of one (1) fast-fix flex broke off while tensioning the knot down.The residual suture was removed with a shaver.There was a non significant-delay, with no additional anesthesia being required, and the procedure was completed using the same device.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: case-(b)(4).H2: additional information on b5, e1, e2, e3 & h6 (health effect - impact code).
Event or Problem Description
It was reported that, during 3-4 procedures, the suture of the fast-fix flex devices broke off while tensioning the knot down.The residual suture was removed with a shaver.There were non significant-delays, with no additional anesthesia being required, and the procedures were completed using the same devices.It is unknown the exact number of patients who experienced this issue or the outcomes for the patients involved.No additional information was provided.

• 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: 24876182
• Report Number: 1219602-2026-01079
• Device Sequence Number: 10002401
• Product Code: GAT
• UDI-Device Identifier: 00885556780800
• UDI-Public: 885556780800
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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: 2201550
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 04/29/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/20/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2025
• 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