MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 9-0 S/A V100-3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2894G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.H6 component code: g07002 device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: what was done to retrieve the needle? for example, another incision, or second surgery? the needle wasn¿t found.Too small for magnetic pickup.What tissue was being sutured when the event occurred? deep inferior epigastric vessel.If the needle piece remains in the patient: in what tissue structure the broken needle was located? is there any plan in place to remove the needle piece in the future? white lap sponges beneath the anastomosis.What is the surgeon's opinion of the needle being retained in the patient? it wasn¿t in the patient.They weren¿t very concerned due to the size of it.What is the procedure name? diep free flap.
Event or Problem Description
It was reported that a patient underwent a diep free flap procedure on an unknown date and suture was used.The needle popped of the suture during the case.They did not retrieve the needle due to not being able to locate it with the x-ray due to the very small needle size.They got another suture to complete the rest of the case without patient harm.It was also reported that the needle wasn¿t in the patient.They weren¿t very concerned due to the size of it.Additional information was requested.

• Brand Name: ETHLN BLK 5IN 9-0 S/A V100-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19649999
• Report Number: 2210968-2024-06812
• Device Sequence Number: 6624941
• Product Code: GAR
• UDI-Device Identifier: 10705031004276
• UDI-Public: 10705031004276
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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: 2894G
• Device Lot Number: TPMECL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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