MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y399H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what tissue type and location of the suture placement? what tissue dehisced? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was suture initially placed (interrupted or continuous)? was there any precipitating stress factor for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during re-operation? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? analysis summary: visual inspection of eleven unopened samples and no defects were found on the package.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage or suture breakage were noted.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.The device performed without any defect noted.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.(b)(4).
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2021 and suture was used.One day post-op, the incision had dehisced, and the patient's bowels were coming out.The patient was rushed to operating room where the surgeon believed that the suture failed at the midline of the incision.The patient doing fine and was discharged (b)(6) 2021.Additional information requested.

• Brand Name: MCRYL VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11530082
• Report Number: 2210968-2021-02564
• Device Sequence Number: 5425081
• Product Code: GAN
• UDI-Device Identifier: 10705031059108
• UDI-Public: 10705031059108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: Y399H
• Device Catalogue Number: Y399H
• Device Lot Number: QJMJLB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/19/2021
• Patient Sequence Number: 1