MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX AB ASSEMBLY - REV CURVE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72201495
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the t2 of the ultra fast-fix did not trigger.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(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.
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, t2, and suture were returned on the device.The t1 is behind the dimple.The variable depth straw was not returned.Bio debris is present.A functional evaluation was performed on the returned device and found that the actuator is able to push the t2 past the dimple for deployment.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 failure include failure to fully actuate the device during implantation.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: ULTRA FAST-FIX AB ASSEMBLY - REV CURVE
• 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: 20875397
• Report Number: 1219602-2024-02747
• Device Sequence Number: 7804273
• Product Code: GAT
• UDI-Device Identifier: 03596010597236
• UDI-Public: 3596010597236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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 Expiration Date: 09/29/2026
• Device Catalogue Number: 72201495
• Device Lot Number: 2081028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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