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	Foreign Body In Patient (2687)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2022 and suture was used.The tip of the needle broke off during the subcuticular closure.X-ray was done and the tip could be seen but the surgeon was unable to retrieve it.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).(b)(4).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.What measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? are any plans in place to remove the needle piece in future? if yes, please provide the date (mm/dd/yyyy).What tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? 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, or its employees that the report constitutes an admission that the product, ethicon, 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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/22/2022 additional information was requested, the following was obtained: ¿ what measures were taken to retrieve the broken piece? x-ray and attempted to retrieve ¿ was there any additional tissue damage as a result of searching for the needle piece? no ¿ are any plans in place to remove the needle piece in future? if yes, please provide the date (mm/dd/yyyy) no ¿ what tissue structure the broken needle was located? subcuticular ¿ what is the surgeon's opinion of consequences to the patient? it will work its way out or lay dormant 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.

• 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: 15170144
• Report Number: 2210968-2022-06318
• Device Sequence Number: 12342898
• Product Code: GAM
• UDI-Device Identifier: 10705031039667
• UDI-Public: 10705031039667
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 09/30/2022
• Device Model Number: J416H
• Device Catalogue Number: J416H
• Device Lot Number: LLK340
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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