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

Model Number	J486H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2001
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained via: what was the initial procedure? joint replacement.What is the procedure date? (b)(6) 2021.What was used to complete the procedure? used another suture.Did the patient suffer from any consequence due to the issue? no.Is there any photo available for visual analysis? there isnt any photo for analysis.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's related to the reported complaint condition were identified.Note: events reported via 2210968-2021-07842, and 2210968-2021-07844.
Event or Problem Description
It was reported that a patient underwent a joint replacement procedure on (b)(6) 2021 and suture was used.During the procedure, the suture got detached from the needle.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 36IN 1 S/A CP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12392166
• Report Number: 2210968-2021-07845
• Device Sequence Number: 3476440
• Product Code: GAM
• UDI-Device Identifier: 10705031040397
• UDI-Public: 10705031040397
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 08/07/2021

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: 12/31/2025
• Device Model Number: J486H
• Device Catalogue Number: J486H
• Device Lot Number: RAMCBL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1