MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M649G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One straight packet with three needle suture combinations, one suture and one detached needle was received for analysis.The product code m649g is multi-strands and contains four strand per packet.Upon visual assessment of the needles, no issues related to breakage needle were observed.However, an incorrect swage was found in one needle, since the swage mark was light.This caused that the suture was detached of the needle.In addition, the needles were tested by resistance test and met the requirements.Based on the information currently available, an incorrect swage issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested, and the following was obtained via: did the needle piece fall into the patient? unk 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? if not retrieved, in what tissue structure the broken needle was retained? is there any plan in place to remove the needle piece in the future? please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager) jjkk qa staff, (b)(6).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.Tracking number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was reported by a sales rep that, during an unknown surgery, the needle was broken during use.It was not a control release needle.Another product was used to complete the case.When we send the sample to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Further details are not provided from the hp.Affiliate reference number.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: STLESS STEEL SIL 4X18IN 6 S/A V-40
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22541723
• Report Number: 2210968-2025-08332
• Device Sequence Number: 12880910
• Product Code: GAQ
• UDI-Device Identifier: 10705031045415
• UDI-Public: (01)10705031045415(17)291231(10)1063000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: M649G
• Device Lot Number: 1063E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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