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

Catalog Number	8682H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.It was reported by the distributor that: surgeon was suturing patient skin closed when noticed that needle at the end broke off.Looked for suture needle in sterile field but was unable to find it.The suture was not found on or in the patient in x-ray image.No other details provided.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/14/2026.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.Additional information was requested, the following was obtained: could you please provide the lot #? does a fragment of the needle remain in the patient¿s tissue? no ,as per our report details.Please read our report.If yes, was more than half the needle retained in the patient? is there any plan in place to remove the needle piece in the future? if yes, could you please provide the scheduled date for the removal? in which tissue structure was the broken needle located? what is the surgeon's opinion of the potential consequences for the patient? no harm reported 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.

• 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.-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: 50753775
• Report Number: 2210968-2026-09128
• Device Sequence Number: 15759167
• Product Code: GAW
• UDI-Device Identifier: 10705031018891
• UDI-Public: (01)10705031018891(17)290831(10)103M3B
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• 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: 8682H
• Device Lot Number: 103M3B
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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