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

Catalog Number	72201494
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during knee arthroscopy, seven (7) ultra fast-fix devices consecutively experienced premature deployment of the ts.Three (3) devices failed internal to the patient.Of the three (3) fat fix that failed inside the patient, five t-implants were left secured in the patient in total.Three t1 and two t2.No t-implants were removed.The procedure was completed using a s+n backup device.There was a surgical delay of less than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
H10: 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 information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: h3, h6: part of the reported devices were received for evaluation.A visual inspection revealed they returned in original packaging with the batch number of the complaint on the labels, none of the three variable depth straw was returned and bio debris is present on the devices.For device one, the t1 and most of the t2 have been cut from the suture and were not returned.For device two, the t1 and the t2 have been cut from the suture and were not returned.For device three, the t1 has been cut from the suture and were not returned, the t2 has been off the needle and placed back on, there appears to be additional implant pieces inside the needle channel.A functional evaluation could not be performed because both implants have already been deployed for all three devices.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications 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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include an unintended inappropriate or excessive force allowing the device to prematurely deploy.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ULTRA FAST-FIX AB ASSEMBLY - CURVED
• 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: 21139074
• Report Number: 1219602-2025-00098
• Device Sequence Number: 6825243
• Product Code: GAT
• UDI-Device Identifier: 03596010597229
• UDI-Public: 3596010597229
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K072322
• 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
• Report Date (Section B): 04/24/2025

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: 72201494
• Device Lot Number: 2135298
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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