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

Model Number	J416H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a 3c episiotomy repair procedure on (b)(6) 2023 and suture was used.The suture was given to the md and a stitch was attempted.The metal needle broke in two in the patient's tissue.The physician had a difficult time trying to find the broken piece, but the needle piece(s) were retrieved during the same procedure.There were no adverse patient consequences.Additional information was requested.
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.Additional information was requested and the following was obtained: did the needle fall into the patient? no.If yes, ¿ was the needle piece(s) retrieved during the same procedure? yes.¿ were x-rays taken to locate the needle piece(s)? no.¿ what measures were taken to retrieve the broken piece? yes.¿ was there any additional tissue damage as a result of searching for the needle piece? no.¿ what tissue structure the broken needle was located? perineum.¿ what is the surgeon's opinion of consequences to the patient? none.Attempts are being 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.Component code: (b)(4)¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.This medwatch report is in response to receipt of a voluntary medwatch report mw1402760000-2023-8005.

• Brand Name: VCL CT BRD UD 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.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16611883
• Report Number: 2210968-2023-02047
• Device Sequence Number: 17357282
• Product Code: GAM
• UDI-Device Identifier: 10705031039667
• UDI-Public: 10705031039667
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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

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: J416H
• Device Catalogue Number: J416H
• Device Lot Number: SDMMQQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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: 26 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: Black Or African American