MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B452
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).Date sent to the fda: 6/19/2026.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.H6 component code: g07002 no device problem found.H6 component code: c22 - photo analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to eth for evaluation.One labeled winding former with one detached needle and one dispensed suture were received for analysis.Product code sxmp1b452.To complement this analysis, one photo was provided; and showed a labeled winding former inside a plastic bag.During examination, a short insertion length was observed at the suture end, and no remnant was found within the needle barrel hole.Visual inspection determined that the needle and suture were detached because the suture insertion did not meet the specified acceptance criteria.Based on the information currently available, the short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an laparoscopic extensive hysterectomy procedure on (b)(6) 2026 and barbed suture was used.The problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery (sxmp1b452/109agu.Changed to another one to continue the surgery (sxpp1a405/10abd4, and the fixation feature was found detached during surgery.Besides, the suture broke.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: STRATAFIX
• 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: 25563423
• Report Number: 2210968-2026-06499
• Device Sequence Number: 13332274
• Product Code: GAM
• UDI-Device Identifier: 10705031470095
• UDI-Public: (01)10705031470095(17)270531(10)109AGU
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: SXMP1B452
• Device Lot Number: 109AGU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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