MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to fda: 1/4/2024.H6 component code: g07002 - device not returned 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.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.The event occurred during multiple procedures ¿ a total of 2 procedures ¿ 1st procedure: implant second stage surgery on (b)(6) 2023.Box of remaining pga sutures with lot number already been sent for analysis ¿ some sutures (needles) broke during the removal from the package, others during use on patients ¿ 2nd procedure: upper implant-supported denture (hybrid).Implant placement x6 on (b)(6) 2023.Box of remaining pga sutures with lot number already sent for analysis (same lot number/box as above) ¿ some sutures (needles) broke during the removal from the package, others during use on patients additional information was requested, the following was obtained: additional information states ¿some sutures (needles) broke during the removal from the package, others during use on patients¿ (b)(4) ¿ procedure 1 - implant second stage surgery on (b)(6) 2023 did both suture breakage and needle breakage occur during use on patient? how many sutures broke during the procedure? how many needles broke during the procedure? (b)(4) ¿ procedure 2¿ implant placement on (b)(6) 2023 did both suture breakage and needle breakage occur during use on patient? how many sutures broke during the procedure? how many needles broke during the procedure? 3 sutures/needle broke during each procedure related reports: 2210968-2023-07618, 2210968-2024-00093, 2210968-2024-00094.
Event or Problem Description
It was reported that a patient underwent a dental implant placement procedure on (b)(6)2023 and suture was used.It was reported that sutures keep breaking easily during procedures.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A SH
• 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: 18443958
• Report Number: 2210968-2024-00094
• Device Sequence Number: 18178995
• Product Code: GAM
• UDI-Device Identifier: 10705031038738
• UDI-Public: 10705031038738
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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: J316H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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