MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J443H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.- was there any adverse consequence associated with the patient? the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via 2210968-2023-06794.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the unknown procedure, the suture was used by a surgeon and it happened where it popped off.Another lot was able to produce second field.Having separation of the needle and the suture is the issue.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/17/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.The functional testing was conducted on the returned devices.The returned samples determined that it was received two unopened samples that pertain to the product code j443h, lot tcmbqb.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.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.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/12/2023.Additional information was requested, the following was obtained: our lab has received extra products: 30 osp and 3 ndl of lot tgmcxb and 26 osp of lot tdmcpp.The original lot number reported to us is tcmbqb.Can you please confirm which lot number is specific to this event? if lots gmcxb and/or tdmcpp are not involved in this event, can you please provide explanation of why they were returned? evidently they pulled these other two lots and tried to recreate the seperation outside of the sterile field.I apologize for the confusion.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.Product complaint # (b)(4).Date sent to the fda: 10/12/2023.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 UD 27IN 2-0 S/A FS-1
• 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; col salvacar; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17759393
• Report Number: 2210968-2023-06795
• Device Sequence Number: 17805884
• Product Code: GAM
• UDI-Device Identifier: 10705031039957
• UDI-Public: 10705031039957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 10/17/2023

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: J443H
• Device Lot Number: TCMBQB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 09/21/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/12/2023; 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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