MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 2-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J775D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 information was requested, and the following was obtained: can you identify the lot number of the product that was used?: unk.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.Reported product code: j775d.Reported lot number: tkmehm.The lot and product do not match.Lot number tkmehm corresponds to product code jb84111.***please clarify the product code and lot number.Is the lot number unknown? d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Investigation summary = > the product received for analysis was identified as product code j775d.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed in the body s 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 (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 revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.A cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile 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.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2024 and suture was used.It was found that the needle was broken before use.No pieces fell into the patient.There were no adverse consequences to the patient.Product was returned and evaluated and found broken.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 9/30/2024.Additional information was requested, the following was obtained: reported product code: j775d.Reported lot number: tkmehm.The lot and product do not match.Lot number tkmehm corresponds to product code jb84111.Please clarify the product code and lot number.Is the lot number unknown? unk.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 2-0 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: 20179345
• Report Number: 2210968-2024-09411
• Device Sequence Number: 21065764
• Product Code: GAM
• UDI-Device Identifier: 10705031042933
• UDI-Public: 10705031042933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: J775D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/30/2024
• 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