MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 6-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J212H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) batch number, and no non-conformances were identified.Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent a nephroureterectomy procedure on (b)(6) 2019 and suture was used.The suture was fraying and cutting through tissue like barbs.It is unknown what was used to complete the procedure successfully.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/24/2020.Additional information: d10, h6.Additional h-3 summary: eighteen unopened samples of product code j212, lot mm6938 were received for analysis.During visual inspection of eighteen unopened samples, no defects on the packets were noted.The samples were opened, and open braid defect was observed along of strands.Per the condition of the samples, the assignable cause of performance fraying suture intra-op, is open braid defect.Three unopened samples of product code j212, lot mm6938 were received for analysis.No defects were found on the packages.The samples were opened and the swage and attachment area needles were observed to be as expected.The sutures were dispensed without problems and test tactile was performed on sutures and no defects, damage or fraying suture along of the strand were noted.Per the condition of the representative samples, no performance ¿ fraying suture intra-op was found.

• Brand Name: VCL CT BRD UD 27IN 6-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9405396
• Report Number: 2210968-2019-90457
• Device Sequence Number: 2450262
• Product Code: GAM
• UDI-Device Identifier: 10705031038196
• UDI-Public: 10705031038196
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 10/31/2023
• Device Model Number: J212H
• Device Catalogue Number: J212H
• Device Lot Number: MM6938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1