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

Model Number	J519H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number rcmbdz / j519w05, and no non-conformances related to the reported complaint condition were identified.Attempts are being made to receive a device.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 attempts are being made to clarify 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.Was the procedure delayed due to the event? if yes, please specify.Were there any patient consequences due to the event? events were submitted via 2210968-2021-06187, 2210968-2021-06188, 2210968-2021-06190 and 2210968-2021-06191.
Event or Problem Description
It was reported that the patient underwent a total knee arthroplasty on (b)(6) 2021 and the suture was used for knee capsule closure.During surgery, the suture broke.Another like suture was used to complete the procedure successfully.Additional information has been requested.

• Brand Name: VCL CT BRD VIO 36IN 1 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12147651
• Report Number: 2210968-2021-06189
• Device Sequence Number: 19827291
• Product Code: GAM
• UDI-Device Identifier: 10705031040892
• UDI-Public: 10705031040892
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 02/28/2026
• Device Model Number: J519H
• Device Catalogue Number: J519H
• Device Lot Number: RCMBDZ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1