MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y426H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported that there was one needle more than expected in the newly dispensed suture when preparing for surgery.Changed another one to complete the surgery.There is no report on patient's injury.According to sale rep feedback by phone, this code should be one needle suture, but open the package, the product is two-arm needle suture, not only extra needle.Please see attached photo.No additional information could be provided.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One empty open foil, one paper lid and one winding former with two reparked strands were received for analysis.The product code y426h is single armed.Upon visual inspection of the received sample, two strands of the same product code were observed, rather than a single strand.The swage and attachment area were observed to be as expected.However, marks that appear to be caused by a surgical instrument were observed on the body needles.The sutures pieces were examined, and body fluids were noted along the strands.However, two photos were provided, and in the first photo it showed one labeled winding former with two undispensed strands resulting in a wrong number of strands in the package.The second photo showed the same condition of the physically received sample.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.

• Brand Name: MCRYL UD 27IN 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: 23466627
• Report Number: 2210968-2025-12502
• Device Sequence Number: 15974720
• Product Code: GAN
• UDI-Device Identifier: 10705031059146
• UDI-Public: (01)10705031059146(17)290930(10)104A1Z
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: Y426H
• Device Lot Number: 104A1Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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