MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 2-0 D/A ST-70; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8400
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic low anterior resection for colorectal cancer procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported by a sales rep that the needle had been detached from the suture.It occurred with two sutures in a row.The product was used on the rectum.It was not a control release needle.Additional suture was performed to complete the case.There was no problem to the patient.Only one needle has been retrieved.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).H3 investigation summary: the product was returned to ethicon for evaluation.One open box with nine representative unopened samples was received for analysis.Product code w8400.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.H6 component code: g07002 - no device problem found 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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, and the following was obtained via: ·no pieces were left inside the patient and no pieces fell into the patient because the suture was detached from the needle.It was possible to use another product immediately when the suture was detached from the needle.This product has double-armed suture and the other needle was used to complete the suture after the suture was detached from the needle."it was reported that ""only one needle has been retrieved"".Please confirm if the needle fell inside the patient and could not be retrieved or if only one affected needle was retrieved to return for analysis.May be return.If the needle piece remains in the patient: what tissue structure the broken needle was located? is there any plan in place to remove the needle piece in the future? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (b)(4) please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.We regularly contact with sale rep about the device returning.

• Brand Name: PRLNE BLU 30IN 2-0 D/A ST-70
• 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: 22196026
• Report Number: 2210968-2025-06721
• Device Sequence Number: 9244278
• Product Code: GAW
• UDI-Device Identifier: 10705031128019
• UDI-Public: (01)10705031128019(17)300228(10)106SZ5
• 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): 06/12/2025

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: W8400
• Device Lot Number: 106SZ5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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