MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A PS PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	585H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a whipple procedure on (b)(6) 2024 and a suture was used.During the procedure the needle broke while suturing unknown tissue.Broken fragment was not recovered.An x-ray was not done.Another like device was used to continue with the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested, and the following was obtained: it was reported that " broken fragment was not recovered.An x-ray was not done." - did any needle piece(s) fall into the patient? it is assumed that the tip is in the patient.- what measures were taken to search for the broken piece(s)? manual search, no xray done since the it was tip only and less than 14mm which is the minimum size required to necessitate xray at this facility.- will an x-ray be performed in the future? please provide details.Not unless patient develops abscess or any other post-op complication.- what is the surgeon's opinion of the possibility of the needle being retained in the patient? are there any plans to continue searching for the needle inside the patient or any different post op treatment? is there any plan in place to remove the needle piece(s) in the future? please provide details.Surgeon realizes it was just the tip so they searched but then continued the case.No plans for post-op unless patient develops complications.- was there any additional tissue damage as a result of searching for the needle piece(s)? no.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: 3/6/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: ETHLN BLK 18IN 2-0 S/A PS PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21172794
• Report Number: 2210968-2025-00650
• Device Sequence Number: 4276581
• Product Code: GAR
• UDI-Device Identifier: 10705031006393
• UDI-Public: (01)10705031006393(17)270930(10)SLBDER
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 585H
• Device Lot Number: SLBDER
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2022
• 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 Sex: Unknown