MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NOVOSTITCH CARTRIDGE 2-0; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	CTX-R001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a radius meniscus tear repair, the surgeon tied the knot and repaired the meniscus tear but after a while the novostitch cartridge 2-0 suture broke, and the repair site was opened again.The suture was removed from the patient with a grasper.Surgery was completed with a back-up device instead.There was a delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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
H10 h3, h6: part of the device, used in treatment, was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The depleted suture cartridge was returned with no suture fragments.The cartridge is undamaged.Based on the condition of the product material found during visual inspection, no fracture of the implant could be confirmed.Additional material testing is not required.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 review of the suture specifications, the sutures are expected to have a minimum average of 3.97lbf (1.80 kgf) tensile strength.A certificate of analysis with the results is required with each lot, to confirm the suture diameter, knot-pull tensile strength, straight pull tensile strength.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 excessive force on the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: NOVOSTITCH CARTRIDGE 2-0
• 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: 22669071
• Report Number: 3009131204-2025-00012
• Device Sequence Number: 17063281
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 853541006105
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K180531
• Number of Events Summarized: 1
• Summary Report (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
• Report Date (Section B): 05/19/2026

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: CTX-R001
• Device Lot Number: M240230
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 05/19/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/05/2025; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• 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