MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 DA V-7 10PLG; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	PXX77N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During the procedure, the needle broke off easily.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.H6 component code: g07002 device not returned 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.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.Please confirm if the needles broke during surgery or the needles pull of from the suture during surgery: did the needle fall into the patient? if yes, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? does a piece of the needle remain in the patient¿s tissue? if yes, is there any plan in place to remove the needle piece in the future? if yes, please provide the scheduled date.What tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? -device return status.Please document the shipment tracking number a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Note: related events reported via 2210968-2024-00768, 2210968-2024-00769, 2210968-2024-00770, 2210968-2024-00771, 2210968-2024-00773.
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.Additional information was requested and the following was obtained: did the needle fall into the patient? yes, in the chest cavity.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? unsure.Was there any additional tissue damage as a result of searching for the needle piece? no.Does a piece of the needle remain in the patient¿s tissue? no.Device return status.Please document the shipment tracking number: a box has not been sent to me to ship back product.Please provide the source or name of person providing answers to follow-up questions: sasha p vega.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 DA V-7 10PLG
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 18606029
• Report Number: 2210968-2024-00772
• Device Sequence Number: 2820861
• Product Code: GAT
• UDI-Device Identifier: 10705031462267
• UDI-Public: 10705031462267
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 02/20/2024

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: PXX77N
• Device Lot Number: TJMEQK
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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