MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A306
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a facial closure procedure on (b)(6) 2026 and barbed suture was used.During the procedure, it was reported by a sales rep that, during hepatobiliary and pancreatic surgery, the suture was detached from the needle when sxpp1a306 was used for fascial closure.The situation was that as the wound was sutured at the end of the surgery, the suture was detached from the needle when the stitches were pulled.At that point, the suture was cut and the wound was closed by overlapping the area with vcpb725d.The product has been discarded.It was not a control release needle.Additional suture was performed to complete the case.No sample will be returned.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.The manufacturing records could not be reviewed as the batch/lot number is unknown.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/18/2026.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.Additional information was requested, the following was obtained: did the reported issue contribute to any patient adverse consequences? unk.- could you please provide the lot number? unk.- please provide the source or name of person providing answers to follow-up questions: (b)(6).

• Brand Name: STRATAFIX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25058439
• Report Number: 2210968-2026-04784
• Device Sequence Number: 21189007
• Product Code: NEW
• UDI-Device Identifier: 10705031245228
• UDI-Public: 10705031245228
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141776
• 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,Followup
• Report Date (Section B): 05/01/2026

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: SXPP1A306
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/18/2026
• 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