MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 1 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J519H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.The single complaint was reported with multiple events.There are no additional details regarding the additional events/quantity.
Event or Problem Description
It was reported that the patient underwent a total knee replacement surgery in 2019 and the suture was used.During closing the joint knee capsule, the suture broke.The procedure was not delayed.There were no patient consequences reported.Additional information will be requested.
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: lot mm5093, mfg.Date - 11/29/2018, exp.Date - 10/31/2023.Lot mkz742, mfg.Date - 9/14/2018, exp.Date - 8/31/2023.In addition, a review of the manufacturing record evaluation for the possible batch number was performed for the finished device lot, and no non-conformances were identified.It was reported that the device had performance breakage suture.It was received for analysis two sealed boxes and two opened boxes with twenty -one and twenty -eight unopened samples of product code j519, lot mm5093.As total 121 unopened samples were received for evaluation.During the visual inspection of thirty-two samples, no defects were found on the packages.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 of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.It was received for analysis a sealed box and fifteen unopened samples of product code j519, lot mkz742.During the visual inspection of thirteen samples, no defects were found on the packages.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 of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.Fourteen unopened samples of product code j519, lot mm5093.The complaint issue was not received for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.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 of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.Thirty-five unopened samples of product code j519, lot mkz742 were returned for analysis.The complaint issue was not received for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.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 of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: VCL CT BRD VIO 36IN 1 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8801135
• Report Number: 2210968-2019-84440
• Device Sequence Number: 2484777
• Product Code: GAM
• UDI-Device Identifier: 10705031040892
• UDI-Public: 10705031040892
• Combination Product (Y/N): N
• 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): 06/21/2019

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 Catalogue Number: J519H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/26/2019
• Patient Sequence Number: 1