MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NOVOSTITCH PRO, SIZE 20; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	CTX-A003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.We are unable to perform a device history review, since batch number information was not provided.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no 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 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.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that on registry review "2025 new zealand acl registry implant report", an unknown number of patients had a failure of the implants after an acl procedure where two (2) novostitch pro devices were used.Patients required revision surgery.Patients outcome is unknown.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference (b)(4) h11 d3, g contact office: manufacturer information corrected.This report was inadvertently submitted under manufacturer report number ¿3009131204-2025-00015¿, correct manufacturer report number is ¿1219602-2025-00015¿.

• Brand Name: NOVOSTITCH PRO, SIZE 20
• 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: 23062872
• Report Number: 3009131204-2025-00015
• Device Sequence Number: 9662685
• Product Code: GAT
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K180531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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?: No
• Device Catalogue Number: CTX-A003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown