MAUDE Adverse Event Report: Ethicon Inc. Coated VICRYL; Suture, Absorbable, Synthetic

Catalog Number	VCPB840D
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 (b)(6) 2026 and suture was used.During surgery, the needles were detached too easily.Three packages from the same lot were opened, but they all had the same defect, so the remaining three unopened packages from the same lot were also retrieved.It was a control release needle.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Additional information was requested, and the following was obtained: - did the reported issue contribute to any patient adverse consequences? no.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- 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.H3: investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one winding former with a suture and eight used needles outside the foil packet was received for analysis.Product code vcpb840d is a control-release product configuration containing eight (8) single-armed suture strands per packet.Upon visual inspection of the returned needles, the swage and attachment areas were noted to be as expected.The barrel hole of the needles was examined under 20x magnification, and no suture remnant was noted.The suture was examined, and the insertion mark could be observed to be as expected.The force used to detach the needle from the suture could not be determined.As part of the eth quality process, all devices are manufactured, inspected, and released to approved specifications.Given the current condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Device history review: a manufacturing record evaluation was performed for the finished device 10c6xd / vcpb840d batch number, and no non-conformances were identified.Expiration date: oct/31/2030 date of mfg.: nov/13/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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: Coated VICRYL
• 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 ; +1(303)552-6892
• MDR Report Key: 50870712
• Report Number: 2210968-2026-09527
• Device Sequence Number: 9224097
• Product Code: GAM
• UDI-Device Identifier: 10705031056626
• UDI-Public: (01)10705031056626(17)301031(10)10C6XD
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K181652
• 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): 09/23/2026

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: VCPB840D
• Device Lot Number: 10C6XD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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