MAUDE Adverse Event Report: Ethicon Inc. STRATAFIX; Suture, absorbable, synthetic, polyglycolic acid

Catalog Number	SXMP1B119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a skin closure procedure on an unknown date and barbed suture was used.During the procedure this barbed suture code has been breaking as they close the skin.They have been closing with this suture for a long time and never had issues.No delay or patient harm was reported.They noticed that it has been the last couple of cases that they have used the product on.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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: 1.If possible, please confirm the number of procedures/patients affected by this issue: there were at least 3 cases.2.How many devices demonstrated the alleged deficiency on each involved patient event? 5 sutures showed the deficiency.3.When did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during passage through tissue 4.Were there any patient consequences? none were reported.Device history review a manufacturing record evaluation was performed for the finished device batch 10e9qz, sxmp1b119-16 and no non-conformances were identified.Mfg.Date - 03/19/2026 exp.Date - 02/29/2028 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.

• 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 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50820745
• Report Number: 2210968-2026-09440
• Device Sequence Number: 10127655
• Product Code: GAM
• UDI-Device Identifier: 10705031236745
• UDI-Public: (01)10705031236745(17)280228(10)10E9QZ
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: SXMP1B119
• Device Lot Number: 10E9QZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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