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

Catalog Number	CTX-A003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a procedure, the novostitch pro men broke on the cart side.The procedure was completed without surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference number: (b)(4).H2: additional information on: b5, e1, e2, e3, g2 & h6 (impact code).
Event or Problem Description
It was reported that during a meniscus repair, the novostitch pro men the needle tip broke off while attempting to pass the suture, the broken pieces were removed using arthroscopic instruments.The procedure was completed without surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not received for evaluation.However, another device was received.A visual inspection of the returned device found that they are sealed in their original unopened packaging.A functional assessment of the devices found that the tested devices actuated, repeatedly, as designed with no breakage of the needles.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.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.
Additional Manufacturer Narrative
H11: internal complaint reference: case-(b)(4).H2: corrected data on d3 & g section (contact office - manufacturing site) this report was inadvertently submitted under manufacturer report number: 3009131204, correct manufacturer report number is 1219602.

• Brand Name: NOVOSTITCH PRO MEN RPR SYS 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: 22026988
• Report Number: 3009131204-2025-00006
• Device Sequence Number: 9099408
• Product Code: GAT
• UDI-Device Identifier: 00853541006112
• UDI-Public: 853541006112
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2026

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-A003
• Device Lot Number: M250017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 06/18/2025; 05/14/2026
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/19/2025; 06/19/2025; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2025
• 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