MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURES - NON-ABSORBABLE

Catalog Number	EP8704SLH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.During surgery dr bhargav patel complained that while using suture code ep8704slh the needle got seperated from the suture material from the swage point during the first byte.Prolene blu 24in 7-0 d/a cc175-8 ep (ep8704slh) : not applicable prolene blu 24in 7-0 d/a cc175-8 ep (ep8704slh) : lot/batch number: 10aem1 list any j&j products that were utilized during the case but did not contribute to the reported event.## *** was there any reported patient or user harm? ## no *** was there a significant delay? ## no *** if available, provide the product order number (po).## *** prolene blu 24in 7-0 d/a cc175-8 ep - ep8704slh (lot: 10aem1) is the actual device with the alleged product quality issue being returned for analysis? or is an alternative device being returned? please specify complaint suture discarded additional h11: list any j&j products that were utilized during the case but did not contribute to the reported event.## *** was there any reported patient or user harm? ## no *** was there a significant delay? ## no *** if available, provide the product order number (po).## *** is the actual device with the alleged product quality issue being returned for analysis? or is an alternative device being returned? please specify complaint suture discarded.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.During surgery, complained that while using suture, the needle got seperated from the suture material from the swage point during the first byte.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE
• Common Device Name: SUTURES - NON-ABSORBABLE
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25073553
• Report Number: 2210968-2026-04859
• Device Sequence Number: 10418254
• Product Code: GAW
• UDI-Device Identifier: 10705031206144
• UDI-Public: (01)10705031206144(17)300731(10)10AEM1
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K133356
• 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): 05/04/2026

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: EP8704SLH
• Device Lot Number: 10AEM1
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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