MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 STRAIGHT NDL DELIVERY SY; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72202467
Medical Device Problem Codes	Failure to Fire (2610); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Cartilage damage (4833)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
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 alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a meniscus repair, it was noticed that the fast-fix 360 t2 could not be deployed.Once the grey button was pushed forward for t2, there was no ¿click¿ to deploy the second anchor, and the anchor was stuck in the device shaft.The procedure was resumed, with a delay of less than 30 minutes, and with a change in surgical technique.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: additional & corrected information on: b5 & h6 (impact code).
Event or Problem Description
It was reported that, during a meniscus repair, it was noticed that the fast-fix 360 t2 implant could not be deployed.Once the grey button was pushed forward for t2, there was no ¿click¿ to deploy the second anchor, and the anchor was stuck in the device shaft.The t1 was removed from the patient with a grasper, and pulled on the suture and the implant tore out.The procedure was resumed, with a surgical delay of less than 30 minutes.It is unknown how the procedure was completed.No further complications were reported.
Event or Problem Description
It was reported that, during a meniscus repair, it was noticed that the fast-fix 360 t2 could not be deployed.Once the grey button was pushed forward for t2, there was no ¿click¿ to deploy the second anchor, and the anchor was stuck in the device shaft.The t1 was removed with a grasper and pulled on the suture and the implant tore out.The procedure was resumed, with a surgical delay of less than 30 minutes.The procedure was completed with a change in surgical technique to meniscectomy.No further complications were reported.
Additional Manufacturer Narrative
H11: additional information on: b1, b2, b5, & h6 (clinical code & impact code).Corrected information on: h1 (type of reportable event) & h11 (results of investigation).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
H11: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned with original labeling with the batch number of the complaint on it.The t1, t2, and suture were not returned.Bio debris is present.A functional evaluation showed that the actuator will not move.The gray slider moves freely indicating the push assembly has become inactive.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.During the investigation it was not possible to identify a definitive root cause; however, it was concluded that the potential causes for the reported event include (1) the application of unintended, inappropriate, or excessive force during device use, and (2) user failure to fully actuate the device during the implantation process.The risk management review confirmed that the reported failure is appropriately documented.The overall risk level is considered adequate.Therefore, no additional actions are deemed necessary at this time.

• Brand Name: FAST-FIX 360 STRAIGHT NDL DELIVERY SY
• 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: 23251640
• Report Number: 1219602-2025-02500
• Device Sequence Number: 10414635
• Product Code: GAT
• UDI-Device Identifier: 00885554023060
• UDI-Public: 885554023060
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K121861
• 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): 01/15/2026

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: 72202467
• Device Lot Number: 2152381
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 10/23/2025; 01/14/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/23/2025; 10/30/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2024
• 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