MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J317H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.Additional information was requested, and the following was obtained via: product name: vcl ct brd vio 27in 2-0 s/a sh, product code: j317h, lot number: unk.Product name: vcl ct brd vio 27in 2-0 s/a sh, product code: j317h, lot number: unk.Was there any additional tissue damage as a result of searching for the needle piece? no.Is there any plan in place to remove the needle piece in the future? no.If yes, please provide the scheduled date.Na.What tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? no response from surgeon please provide the lot number: unknown.Please provide the source or name of person providing answers to follow-up questions: or supervisor.Events reported via: (b)(4).User facility medwatch form, #(b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopic sleeve gastrectomy, lysis of adhesions; on (b)(6) 2023 and suture was used.During the procedure, two ethicon needles from a coated vicryl® (polyglactin 910) suture package broke off in site while suturing.The broken fragments were unable to be retrieved.Per policy, no x-ray was required due to size of suturing needle.There were no patient consequences reported.Device is not available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 27IN 2-0 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: 18758779
• Report Number: 2210968-2024-01669
• Device Sequence Number: 15020565
• Product Code: GAM
• UDI-Device Identifier: 10705031038752
• UDI-Public: 10705031038752
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: J317H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/22/2024
• 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 Age: 30 YR
• Patient Sex: Female
• Patient Weight: 94 KG