MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 18IN 4-0 S/A PS-2 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR496
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a right radical nephrectomy procedure on (b)(6) 2023 and suture was used.During the procedure, while pulling to tighten suture, the device broke.They opened up two devices and one of them broke.No patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/15/2023.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested the following was obtained: * please confirm the quantity of sutures that broke.2 * when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify for each of the involved devices.Suture broke during use on the patient.Same for both * please provide the lot number.Do not have lot number, code is vr496 * please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) leah zavalick - ahh account executive 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.Device was shipped on 8/24 at 12:40pm.Tracking number is (b)(4).H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received one needle-suture piece outside from the labeled winding former that pertain to the product code vr496.In order to evaluate the conditions of the returned sample, the suture piece was observed with the extreme cut that was possibly caused by a surgical instrument.In addition, excessive body fluids and fraying were noted along the strand.As per the conditions of the returned sample, no functional test could be performed.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related reports: 2210968-2023-06751.

• Brand Name: VCL RAP UD 18IN 4-0 S/A PS-2 PRM
• 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: 17755605
• Report Number: 2210968-2023-06752
• Device Sequence Number: 12425636
• Product Code: GAM
• UDI-Device Identifier: 10705031134690
• UDI-Public: 10705031134690
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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 Catalogue Number: VR496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/15/2023
• 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