MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y496G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.There is a double needle found on a unidirectional suture.Surgical delay unknown.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H 6.Investigation findings: c22 ¿ photo evaluation.Additional information was requested, and the following was obtained: - is there evidence that could suggest that the reported suture was part of a product mix in the package? no.- are there photos available for visual analysis? yes.The following information was requested, but unavailable: - were there patient consequences? if yes, please explain.Unknown.H3 investigation summary: the product was returned to ethicon for evaluation.One opened sample with two undispensed strands was received for analysis.Product code y496g, this product code is single armed.Additionally, one photo was provided, and it showed one open sample inside its a plastic bag, which is consistent with the actual received sample situation.To evaluate the condition of the returned sample , the suture was removed from the winding former and it was found that had two strand single armed of the same product code instead one strand, resulting in a wrong number of strands in the package.Based on the information currently available, the extra needle suture issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and non-conformances no related to the reported complaint condition 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: MCRYL UD 18IN 4-0 S/A PS-2 PRM MP
• 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: 22707229
• Report Number: 2210968-2025-09015
• Device Sequence Number: 9759552
• Product Code: GAN
• UDI-Device Identifier: 10705031059375
• UDI-Public: (01)10705031059375(17)300131(10)106LHB
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: Y496G
• Device Lot Number: 106LHB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• 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