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	Material Separation (1562)
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
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 h3 investigation summary: the product was returned to ethicon for evaluation.Two detached needles and one suture piece outside its packaging were returned for analysis.Product code j546g requires one strand double-armed per packet.During the visual assessment of the detached needles, the swage and attachment area were as expected.However, marks were noted on the body of the needles and the edge on one needle.The barrel holes of the needles were examined with magnification, and remnant of suture was observed on one needle on the other needle no suture remnant was noted.The suture piece was examined, and on one extreme was noted to be cut marks probably caused by a surgical instrument and on the other extreme, a correct insertion mark was observed; however, the force used to detach the needle from the suture could not be determined.Also, the suture had been partially cut and body fluids were noted along the strand.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.This complaint is about product code j546g.A device from product code j546g was received for analysis.In addition to that device, the following was also received: 1 detached needle and 1 suture piece know product code.Please provide the following information for the additional device received of 1 detached needle and 1 suture piece with an unknown product code: is there a complaint for the product returned of 1 detached needle and 1 suture piece with an unknown product code? if yes, please describe issue.Does this additional product received (unknown product code) belong to this complaint? if the device does not belong to this complaint: why was the device returned? was the device returned in error? does the device belong to a different complaint? if yes, please provide pc number.
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.H6 component code: g07002 device not returned.Attempts have been 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.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 confirm the number of sutures that separated from the needle during this procedure.Please provide the source or name and title of the external person providing answers to follow-up.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the information.To date no response has been provided.If 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 an unknown date and suture was used.During the procedure, the suture and needle separated.It was unknown how the procedure was completed.There were no adverse patient consequences reported.Additional information was requested.
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: after confirming with the sales-rep, it was verbally confirmed on 2024/10/07 that the additional device do not belong to this complaint.

• 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: 19519041
• Report Number: 2210968-2024-06120
• Device Sequence Number: 8412169
• Product Code: GAM
• UDI-Device Identifier: 10705031041097
• UDI-Public: (01)10705031041097(17)280630(10)THMLDB
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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: J546G
• Device Lot Number: THMLDB
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 10/07/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 09/13/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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