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

Catalog Number	VCP603H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.When opening the package, the wire was broken, during the procedure before use.Upon receipt and analysis, a short insertion was noted.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: vcl+ vio 27in 0 s/a ur-6 (vcp603h): affected side: unknown.Reason why product is not available: available.Vcl+ vio 27in 0 s/a ur-6 (vcp603h): lot/lot number: 1078ek.List all j&j products that were used during the case but did not contribute to the reported event.Was there any damage or loss reported by the patient or user? no.Was there a significant delay? no.If available, provide the product order number (po).Product available to be collected: attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.H3 evaluation: the product was returned to eth for evaluation.Visual inspection revealed that one detached needle and one winding former with a suture outside their packaging were received for analysis.Product code vcp603.Upon initial inspection of the returned sample, no evidence of breakage suture could be observed.However, a short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.Based on the information currently available, short insertion issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.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, 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: 50946712
• Report Number: 2210968-2026-09930
• Device Sequence Number: 9534654
• Product Code: GAM
• UDI-Device Identifier: 10705031054394
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: VCP603H
• Device Lot Number: 1078EK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2025
• 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