MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 27IN 2-0 SA CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a knee fixed bearing cemented procedure on (b)(6) 2025 and barbed suture was used.During the procedure, when closing subcutaneous layer during a knee fixed bearing cemented procedure with stratafix spiral monocryl plus, the suture thread broke probably related to the surgeon applying too much tension.No adverse patient consequences were reported.Additional information was requested.Was surgery delayed due to the reported event? no, was procedure successfully completed? no, were fragments generated? yes, if yes, were they removed easily without additional intervention? yes, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4).Device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained via: - when did the suture breakage occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during the passage of the suture through the tissue, while applying normal tension when pulling the thread to bring the wound edges together.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) the event occurred with dott.Matteo jacchini, head of the orthopedics and traumatology department at the città di pavia care institute.However, he is not the designated source for follow-up.No further information is available regarding this matter.Additional h11: was surgery delayed due to the reported event? no, was procedure successfully completed? no, were fragments generated? yes, if yes, were they removed easily without additional intervention? yes, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4).Device property of none, device in possession of none.

• Brand Name: SFXSPI MCL+ UNI UD 27IN 2-0 SA CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23303717
• Report Number: 2210968-2025-11914
• Device Sequence Number: 10192990
• Product Code: GAM
• UDI-Device Identifier: 10705031236400
• UDI-Public: (01)10705031236400(17)270131(10)106EUC
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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 Catalogue Number: SXMP1B414
• Device Lot Number: 106EUC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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