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

Catalog Number	72202467
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (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 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 surgery, the fast-fix 360´s t2 implant triggered too early, right after the t1 implant.The t1 implant was deployed through the meniscus and was removed from inside the patient.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected data on: d4 (lot number & expiration date) & h4.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The t1 was returned off the needle but attached to the suture.The t2 and suture were returned on the needle.The actuator is in the pre-t1/post-t2 position.The needle assembly is bent.Bio debris is present.A functional evaluation was performed on the returned device and found the actuator cycled to the tip, returning to the pre-t2 position, then cycled the t2 off the needle, and continued to cycle as intended.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 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.Other factors that can contribute to the reported event include an unintended second actuation of the device or excessive retraction of the device causing t2 to be pulled from the needle.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was received with original packaging with the batch number 2147052 on the label.The t1 was returned off the needle but attached to the suture.The t2 and suture were returned on the needle.The actuator is in the pre-t2 position.The needle assembly is severely bent.The tip of the needle is bent.A functional evaluation was performed on the returned device and found actuator cannot push the t2 off the needle due to the severe bend in the needle assembly.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 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.Other factors that can contribute to the reported event include an application of unintended inappropriate or excessive force allowing the device to prematurely deploy.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21251939
• Report Number: 1219602-2025-00194
• Device Sequence Number: 20856346
• Product Code: GAT
• UDI-Device Identifier: 00885554023060
• UDI-Public: 885554023060
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/03/2025

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: 72202467
• Device Lot Number: 2150440
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 05/19/2025; 09/01/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/24/2025; 06/05/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2024
• 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
• Patient Sex: Unknown