MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 6IN 3-0 SA RB-1 MP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B449
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/13/2025.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.Additional information was requested; the following was obtained: were there any adverse consequences associated with the patient? did the needle fall into the patient? if so, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were implemented to retrieve the broken piece? was there any additional tissue damage resulting from the search for the needle piece? what is the surgeon's opinion of the potential consequences for the patient? how the patient's surgical progress was affected? - could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.What is the current status of the patient? received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the suturing operation, the tail end of the needle broke and could not be used.It was immediately removed and checked for integrity, and a new needle was replaced to continue suturing.This event has affected the patient's surgical progress.There were no patient consequences reported.Additional information was requested.

• Brand Name: SFX SPI MCRYL+UNI VIO 6IN 3-0 SA RB-1 MP
• 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: 22017812
• Report Number: 2210968-2025-05262
• Device Sequence Number: 13132587
• Product Code: GAM
• UDI-Device Identifier: 10705031470002
• UDI-Public: (01)10705031470002(17)260331(10)100BS0
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K221744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: SXMP1B449
• Device Lot Number: 100BS0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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