MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 3X18IN 1 S/A OS-8 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J718T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device not returned if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the needle piece removed from the patient during the same procedure? was there any additional tissue damage as a result of searching for the needle piece? was additional dissection required in other organs/tissues other than the target tissue? what is the most current patient health status and condition? events reported via: 2210968-2022-01817, 2210968-2022-01818, 2210968-2022-01826, 2210968-2022-01819, 2210968-2022-01820, 2210968-2022-01821, 2210968-2022-01822, 2210968-2022-01823, 2210968-2022-01824, and 2210968-2022-01825.
Event or Problem Description
It was reported that a patient underwent a spine procedure on (b)(6) 2022 and suture was used.During the procedure, multiple strands of suture the needle popped off prematurely.Needle would barely make it through the tissue before the needle would pop off.Multiple like devices were used to complete the procedure as the premature pop off continued to happen throughout the case.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/18/2022.H6 component code: g07002 no device return.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Events reported via: 2210968-2022-01815, 2210968-2022-01817, 2210968-2022-01818, 2210968-2022-01826, 2210968-2022-01819, 2210968-2022-01820, 2210968-2022-01821, 2210968-2022-01822, 2210968-2022-01823, 2210968-2022-01824, and 2210968-2022-01825.

• Brand Name: VCL CT BRD VIO 3X18IN 1 S/A OS-8 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13770807
• Report Number: 2210968-2022-01816
• Device Sequence Number: 3837116
• Product Code: GAM
• UDI-Device Identifier: 10705031042520
• UDI-Public: 10705031042520
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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 Expiration Date: 06/30/2026
• Device Model Number: J718T
• Device Catalogue Number: J718T
• Device Lot Number: RHMDZH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/26/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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