MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 2-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8523H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic gastrostomy procedure on (b)(6) 2025 and suture was used.During a laparoscopic gastrostomy for dysphagia, the product was used on the gastric mucosa for suturing.During the suturing procedure, when the needle was passed through the tissue and pulled, the suture was broken a few times at a point a little away from the swage part.Therefore, the suture was replaced with a new one and the suturing was performed again.It was not a control release needle.Additional suture was performed to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/12/2025.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.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: please clarify, did one suture thread broke multiple times during use on the patient or multiple suture threads broke during use on the patient? =>multiple suture threads broke.If multiple suture threads broke, please provide the number of devices that demonstrated the alleged deficiency.=>14.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.=>we regularly contact with sale rep about the device returning.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).=>(b)(6).The following information was reported: the sales rep had a interview with the surgeon on october 17th and heard the details of the situation.The sales rep explained the characteristics of the prolene material in this product and that the sutures are prone to damage.The sales rep suggested that if the suture was grasped during surgery, this could be the starting point for the tears.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: PRLNE BLU 36IN 2-0 D/A SH
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23534034
• Report Number: 2210968-2025-12719
• Device Sequence Number: 10026753
• Product Code: GAW
• UDI-Device Identifier: 10705031016590
• UDI-Public: (01)10705031016590(17)281130(10)TPBDPT
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/12/2025

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: 8523H
• Device Lot Number: TPBDPT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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