MAUDE Adverse Event Report: ETHICON INC. VCL UC MONO VIO 12IN 10-0 D/A CS160-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	V450G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).A manufacturing record evaluation was performed for the finished device lot number pmz836, and no non-conformances related to the reported complaint condition were identified.(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.Additional information was requested, and the following was obtained: could you please inform the specific number of procedures in which the pull off's occurred? 10+ times over a 3 month period.Could you please confirm the specific quantity of affected devices during each procedure? 1.What was being done when the pull off's occurred (e.G.Removal from package, during passage through tissue, during tying, etc.)? on different occasions, pulling through tissue, doctor tying the suture, loading suture on a needle holder.Names and dates of the procedures? trabeculectomy, pterygium.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.The suture is not available for return.The single complaint was reported with multiple events/procedures.There are no additional details regarding the additional events.
Event or Problem Description
It was reported that the patient underwent a trabeculectomy or pterygium surgery on unknown date and the suture was used.It was reported that the suture was popping off the needle possibly during tying the suture, passing the suture through tissue or during loading the suture.There were no patient consequences reported.

• Brand Name: VCL UC MONO VIO 12IN 10-0 D/A CS160-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11771275
• Report Number: 2210968-2021-04225
• Device Sequence Number: 14514237
• Product Code: GAM
• UDI-Device Identifier: 10705031051270
• UDI-Public: 10705031051270
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 10/31/2024
• Device Model Number: V450G
• Device Catalogue Number: V450G
• Device Lot Number: PMZ836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1