MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 7-0 D/A TG140-8; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J546G
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.When opening the package, it was found that the needle of this suture have come apart and being unusable.No reported adverse patient consequences.Upon receipt and analysis, the needle break was observed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: did the event occur during sterile processing? unknown, did the event occur during field inspection? unknown, did the event occur during internal service activities such as calibration? --> unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, if further details are received at a later date a supplemental medwatch will be sent.H3 evaluation: one complaint sample.The returned sample determined that it was received, one detached needle that pertains to product code.In order to evaluate the conditions of the returned sample, it was observed the needle was broken at the swage area.In addition, the suture was not received for analysis.Escalated for further analysis of the needle breakage.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.The needle was received as one piece, the mating fracture surfaces were not separated from the needle.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of the sample did not reveal the fracture mode.The orientation of cracks and material obscured the fracture surfaces.An adequate examination of the fracture surfaces could not be performed, and fracture mode was not determined during this evaluation.A review of the batch manufacturing records was conducted, and no related 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.

• Brand Name: VCL CT BRD VIO 18IN 7-0 D/A TG140-8
• Common Device Name: SUTURE, ABSORBABLE, 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: 17946548
• Report Number: 2210968-2023-07863
• Device Sequence Number: 12737099
• Product Code: GAM
• UDI-Device Identifier: 10705031041097
• UDI-Public: 10705031041097
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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: J546G
• Device Lot Number: SDMAZC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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