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

Model Number	J371H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance 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.Additional information was requested, and the following was obtained: what was the name of the procedure? total knee.What was the procedure date? (b)(6) 2021.What was used to complete the procedure? unknown.In relation to needle, what is the approximate location of suture breakage? knee.Did the suture separate completely? unknown.What tissue was being approximated or sutured when it broke? unknown.Was there any adverse consequence associated with the patient? unknown.Device return status: sample not available.
Event or Problem Description
It was reported that a patient underwent a knee surgery on (b)(6) 2021 and suture was used.During the procedure, the needle broke.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12329228
• Report Number: 2210968-2021-07390
• Device Sequence Number: 11706996
• Product Code: GAM
• UDI-Device Identifier: 10705031039391
• UDI-Public: 10705031039391
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 08/31/2025
• Device Model Number: J371H
• Device Catalogue Number: J371H
• Device Lot Number: QKMDAX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1