MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CP-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z969H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.What is the total number of products involved in this event? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 device analysis: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that twenty-five packets that pertained to product code z969h were received for evaluation.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.A functional test was performed, and the tensile strength results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure on (b)(6) 2023 and suture was used.During the procedure, it was reported that the suture is breaking while suturing to tie off the poetical and the linier.Another like device was used to complete the procedure.25 sterile samples will be returned.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 2-0 S/A CP-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17144773
• Report Number: 2210968-2023-04383
• Device Sequence Number: 17489442
• Product Code: NEW
• UDI-Device Identifier: 10705031061941
• UDI-Public: 10705031061941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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 Model Number: Z969H
• Device Catalogue Number: Z969H
• Device Lot Number: SKMLBK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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