MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 5-0 S/A TF; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y433H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please explain the '.Suture adverse event that affected the progress of the surgery.' was any additional medical or surgical intervention performed (e.G., product removal, re-operation, re-suturing, re-closure, drainage)? if so, please specify.Please inform the patient¿s current health status and condition.Received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.No product is available for return.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.
Event or Problem Description
It was reported a patient underwent a an unknown procedure on (b)(6) 2025 and a suture was used.During the surgical suture process, the problem of pulling off suture needle had happened, resulting in a suture adverse event that affected the progress of the surgery.Additional information has been requested.

• Brand Name: MCRYL UD 27IN 5-0 S/A TF
• 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: 23040260
• Report Number: 2210968-2025-10450
• Device Sequence Number: 13229237
• Product Code: GAN
• UDI-Device Identifier: 10705031059184
• UDI-Public: (01)10705031059184(17)300131(10)106GRG
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: Y433H
• Device Lot Number: 106GRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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