MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 4X18IN 2-0 S/A UR-6 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D9142
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic appendectomy on (b)(6) 2022 and suture was used.When opening the package, it was found that the needle had been detached from the suture.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Analysis summary: one detached needle and a winding former with three needle-suture combination and one suture of product code d9142 were returned to ethicon for evaluation.This product code is control release, and each packet contains four strands.Visual inspection was conducted on the returned device.After investigation of the sample short insertion was observed in strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.This defect is caused because the suture was not properly inserted inside of the needle barrel hole.Based on the information currently available, the pull-out defect was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.The manufacturing records couldn't be reviewed as the batch/lot number is unknown.

• Brand Name: VCL CT BRD VIO 4X18IN 2-0 S/A UR-6 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15285318
• Report Number: 2210968-2022-06889
• Device Sequence Number: 19406068
• Product Code: GAM
• UDI-Device Identifier: 10705031032163
• UDI-Public: 10705031032163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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 Model Number: D9142
• Device Catalogue Number: D9142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown