MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y604H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a prostate cancer surgery on (b)(6) 2024 and suture was used.It was reported when the doctor used suture to suture and anastomose the urethra during surgery, the suture broke when tightened, resulting in a prolonged anastomosis time and posing a safety hazard to the anastomosis effect.Replace the suture with a new one and continue with surgical suturing, proceeding normally.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 9/3/2024.H6 component code: g07002: device not returned.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.The following information was requested, but unavailable: how long was the anastomosis delay? were there any unexpected outcomes or complications as a result of the prolonged time? contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/15/2024.The following information was received: after investigation, the patient was a male of unknown age.On (b)(6) 2024, the patient underwent radical prostatectomy in hospital.The surgeon used y604h for urethral anastomosis during the surgery.The suture broke during the sewing.The surgeon immediately replaced with a new suture (with specific product information unknown) for sewing.The subsequent surgery went smoothly.This event did not cause any other harm to the patient except for prolonged operation time (specific prolongation time was unknown), and no subsequent adverse event report was received.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 VIO 27IN 3-0 S/A UR-6
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20129342
• Report Number: 2210968-2024-09245
• Device Sequence Number: 17991825
• Product Code: GAN
• UDI-Device Identifier: 10705031059474
• UDI-Public: (01)10705031059474(17)280831(10)TKMMDA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: Y604H
• Device Lot Number: TKMMDA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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