MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y922H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, the doctor pulled out the suture and it broke and disintegrated in hand.Upon evaluation of the returned device, the strand had begun a degradation process.No additional information was provided,.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/21/2023 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.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.The returned sample determined that it was received one labeled winding former with a needle outside its packaging that pertains to product code y922h.Upon visual assessment of the winding former, it was observed that the strand had begun with a degradation process caused by exposure to the environment.In addition, the needle was examined with magnification, and the suture remnant could be observed in the hole.Per the sample condition, the functional test cannot be performed.The foil was visually inspected, and no anomalies were observed during the evaluation.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received one open box with fifteen unopened samples pertain to the product code y922h.As per the sampling plan, a visual inspection was performed on thirteen samples, and no defects were found on the packages.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along of the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.Also, a functional test was performed using instron equipment and tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MCRYL VIO 36IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16791535
• Report Number: 2210968-2023-02928
• Device Sequence Number: 12185404
• Product Code: GAN
• UDI-Device Identifier: 10705031059856
• UDI-Public: 10705031059856
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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 Expiration Date: 05/31/2026
• Device Model Number: Y922H
• Device Catalogue Number: Y922H
• Device Lot Number: RGMLBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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