MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 3-0 S/A PS-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J683G
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
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: it was mentioned in event description:" a total of four of the sutures were used.Two of the four sutures needle tips broke off while in use".Please confirm if only two needle tips broke off during this single procedure? it is reported in event description :"i do not have the broken suture" please confirm if this is one broken suture found during the procedure? what was the quality issue found with the other suture? lot number? are any samples available of evaluation? please provide facility contact person¿s name, mailing address and telephone.A shipper kit will be sent to help return the product to us.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.Related reports: 2210968-2022-05995, 2210968-2022-05996.
Event or Problem Description
It was reported that a patient underwent a unknown procedure on (b)(6) 2022 and suture was used.During the procedure, a total of four of the sutures were used.Two of the four sutures needle tips broke off while in use.They were able to be retrieved by the surgeon.They were all from the same suture box.The broken suture is not available for return.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 08/26/2022.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: h6.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Related reports: 2210968-2022-05995, 2210968-2022-05996, 2210968-2022-05997.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/8/2022 additional information was requested, the following was obtained: *please confirm how many needle tips broke.- 2 *please confirm how many suture threads broke-0.*please confirm how many needles pulled off of the thread-0 *please confirm the total number of devices that malfunctioned.-2 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.Related reports: 2210968-2022-05996.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/19/2022.Additional information was requested, the following was obtained: lot number is pkz314.No samples or product available, correct that two needles broke off from the suture.Attempts are being made to obtain the following information.If further details are received at a later date a supplemental medwatch will be sent: *please confirm how many needle tips broke.*please confirm how many suture threads broke.*please confirm how many needles pulled off of the thread.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.Related reports: 2210968-2022-05995, 2210968-2022-05996, 2210968-2022-05997.

• Brand Name: VCL CT BRD UD 18IN 3-0 S/A PS-1 PRM MP
• 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: 15114271
• Report Number: 2210968-2022-05997
• Device Sequence Number: 20295962
• Product Code: GAM
• UDI-Device Identifier: 10705031042186
• UDI-Public: 10705031042186
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2022

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 Expiration Date: 08/31/2024
• Device Model Number: J683G
• Device Catalogue Number: J683G
• Device Lot Number: PKZ314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 08/05/2022; 08/26/2022; 08/27/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/19/2022; 08/26/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• 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