MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J415H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.The suture slid off the needle during a repair.Patient was sutured with different sutures without any concerns.No patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested.If further details are received at a later date a supplemental medwatch will be sent.Was there any adverse consequence associated with the patient? no.Please provide the lot number: product received/lot.Device return status: returned.Evaluation: one open box with twenty unopened samples of product code were returned for analysis.As per the sampling plan, a visual inspection was performed on thirteen samples, no defects were fund on the packages.The packets were opened, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand no anomalies were observed during evaluation.Also, the functional test was performed using a instron and the tensile force were above the minimum requirements.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.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported on mw# 2210968-2022-04961.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, or its employees that the report constitutes an admission that the product, ethicon, 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 4-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14851781
• Report Number: 2210968-2022-04960
• Device Sequence Number: 4793681
• Product Code: GAM
• UDI-Device Identifier: 10705031039643
• UDI-Public: 10705031039643
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 04/30/2026
• Device Model Number: J415H
• Device Catalogue Number: J415H
• Device Lot Number: REMAPK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown