MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 4-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J773D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.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 provide the lot number.Attempts are being 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.H6 component code: g07002 ¿ device not returned.
Event or Problem Description
It was reported that the patient underwent a pacemaker surgery on an unknown date in 2024 and suture was used.During surgery, the needle broke in half.All pieces of the needles were able to be retrieved.The procedure was completed and no harm was done to the patient.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.H3 analysis summary: the product was returned to ethicon for evaluation.The returned product determined that it was received, one needle and six needle suture combinations that pertain to product code j773.This product code is multistrand and should contain eight strands single armed per packet.During visual inspection of the needle, it was observed that the needle was noted to be broken in the middle.The needle will be shipped to hsa for further analysis due to the needle breakage.The six needle sutures were examined, and the swage and attachment area were noted as expected.The tip and body of the needle were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.No conclusion could be reached due to the sample needs additional evaluation by hsa.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.The manufacturing records could not be reviewed as the batch/lot number is unknown.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 7/8/2024.Additional information: d9, h3, h6.H3 investigational summary: the product received for analysis was identified as product code j773d.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.The needle was noted with marks that appears to be by surgical instrument.A scanning electron microscope 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 revealed the fracture was mixed mode with evidence of both intergranular fracture and microvoid coalescence.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide evidence that the failure was predominantly due to ductile overload.This was a mixed mode fracture.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.There is no evidence of any material flaw that would cause premature failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: VCL CT BRD VIO 8X18IN 4-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19280810
• Report Number: 2210968-2024-05277
• Device Sequence Number: 20413300
• Product Code: GAM
• UDI-Device Identifier: 10705031042896
• UDI-Public: 10705031042896
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: J773D
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/10/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/12/2024; 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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