MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J603H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.During an unknown surgery, the suture was detached from the needle.This issue occurred 2 products in a row.There was no problem with the third one.It was not a control release needle.Another product was used 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: 1/28/2026.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.Additional information was requested, the following: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify unk.Can you identify the lot number of the product involved? -lot number unk 10a1t6, 107bra 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) (b)(6) please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4 expiration date, d4 udi primary udi number, d9, h4.H3 evaluation: the product was returned to eth for evaluation.Visual inspection revealed that one labeled winding with one needle and one suture outside the foil packet was received for analysis.Product code upon visual inspection of the returned sample, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was noted.The suture was examined, and the insertion mark could not be observed.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Given the current condition of the returned sample, it is not possible to determine the potential cause of the reported event.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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: VCL CT BRD VIO 27IN 0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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 ; 3035526892
• MDR Report Key: 24201176
• Report Number: 2210968-2026-01016
• Device Sequence Number: 9624816
• Product Code: GAM
• UDI-Device Identifier: 10705031041639
• UDI-Public: (01)10705031041639(17)300630(10)10A1T6
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: J603H
• Device Lot Number: 10A1T6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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