MAUDE Adverse Event Report: Ethicon Inc. PROLENE; suture, nonabsorbable, synthetic, polypropylene

Catalog Number	8304H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle broke when sewing in surgery.Changed to another one to continue the surgery, the same problem happened.Changed to another one to complete the surgery.The broken needle was retrieved shortly.The procedure was completed and 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.The following information was requested, but unavailable: --received information as following from sales rep via phone today.Please refer to the event description, no patient consequence reported, other information requested is unknown.- did the needle fall into the patient? if yes, ¿ was the needle piece(s) retrieved during the same procedure? ¿ were x-rays taken to locate the needle piece(s)? ¿ what measures were taken to retrieve the broken piece? ¿ was there any additional tissue damage as a result of searching for the needle piece? ¿ if not retrieved, in what tissue structure the needle was retained? is there any plan in place to remove the needle in the future? please provide details.¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) device history review = > a manufacturing record evaluation was performed for the finished device 105zkt / 8304h batch number, and no non-conformances were identified.Expiration date: dec/31/2029 date of mfg.: jan/23/2025 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.

• Brand Name: PROLENE
• Common Device Name: suture, nonabsorbable, synthetic, polypropylene
• 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 ; +1(303)552-6892
• MDR Report Key: 50819735
• Report Number: 2210968-2026-09426
• Device Sequence Number: 10677213
• Product Code: GAW
• UDI-Device Identifier: 10705031014114
• UDI-Public: (01)10705031014114(17)291231(10)105ZKT
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• 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: 8304H
• Device Lot Number: 105ZKT
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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