MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J370H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/22/2024.H6 component code: g07002 - device not returned.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.Additional information was requested, the following was obtained: please find below the information requested: did the needle piece fall into the patient? no.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? piece was visible, suture was removed from case.Was there any additional tissue damage as a result of searching for the needle piece? no.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? is this device or samples form the same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number).Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6).Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Handed to chain supply.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.The needle broke during a procedure.There was no patient consequences reported.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.Additional h6 component code: g07002 no device problem found.Investigation summary : the product was returned to ethicon for evaluation.One empty box and twelve representative unopened samples were received for analysis.Product code j370h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The tip and body of the needles were examined under magnification and no defects or needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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.Investigation summary: the product received for analysis was j370h.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed near the tip of the needle.The needle was noted with marks that appears to be by surgical instrument.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 evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.The needle breakage was confirmed.The evaluation of the sample revealed the fracture was composed of micro void coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL CT BRD VIO 36IN 0 S/A CTX
• 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: 20507655
• Report Number: 2210968-2024-10947
• Device Sequence Number: 20862859
• Product Code: GAM
• UDI-Device Identifier: 10705031039377
• UDI-Public: (01)10705031039377(17)290630(10)102CAH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

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: J370H
• Device Lot Number: 102CAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 11/27/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/11/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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