MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 2-0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J517H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 reported "the needle is breaking off from the suture.The weak point is where the needle and suture are joint together." please clarify: did the needle break or needle pulled off did this occurred during the surgery (intra op) or before the surgery (pre op)? what was the name and date of the procedure? how many needles were " needle is breaking off from the suture" during suturing on this one patient during this single surgical procedure? did the "needle is breaking off from the suture" occurred in multiple procedures? if yes please provide pc number for each of the procedures.Actual device is to be returned.Please clarify the quantity involved if ¿8¿ devices experienced "the needle is breaking off from the suture." or if you mean that only 1 device had the issue of "the needle is breaking off from the suture" and 8 products are to be returned ? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2021 and suture was used.During the procedure, the suture got detached from the needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 9/09/2021.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: investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation, only four top foils were received of product code j517.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 8/16/2021.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: d9 the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: did the needle break or needle pulled off did this occurred during the surgery (intra op) or before the surgery (pre op)? what was the name and date of the procedure? pre op how many needles were " needle is breaking off from the suture" during suturing on this one patient during this single surgical procedure? only 1 did the "needle is breaking off from the suture" occurred in multiple procedures? if yes please provide pc number for each of the procedures 1 actual device is to be returned.Only one procedure please clarify the quantity involved if ¿8¿ devices experienced "the needle is breaking off from the suture." or if you mean that only 1 device had the issue of "the needle is breaking off from the suture" and 8 products are to be returned ? only 1 device was involved, rest of the stock was sent back to head office.

• Brand Name: VCL CT BRD VIO 36IN 2-0 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11643920
• Report Number: 2210968-2021-03209
• Device Sequence Number: 16891035
• Product Code: GAM
• UDI-Device Identifier: 10705031040854
• UDI-Public: 10705031040854
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2021

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: 08/31/2025
• Device Model Number: J517H
• Device Catalogue Number: J517H
• Device Lot Number: QCBBTZQ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 08/17/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 08/16/2021; 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1