MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z398H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: questions: please clarify, when the event occurred? pre-op or intra-op.How the procedure was complete? please provide procedure date.Status of product return / follow up.Answers: it was on (b)(6) 2020 during surgeries, the needle was falling into the body cavity and he had to dig it out.The suture was breaking as he was pulling also.He had to use a different suture to complete surgery.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.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on (b)(6) 2020; and a suture was used.During the procedure, the needle separated from the suture and fell into body cavity; then the suture broke in half while being pulled.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/14/2020.A manufacturing record evaluation was performed for the finished device qcmleq batch number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/06/2020 additional h3 investigation summary: twenty-eight unopened samples of product code z398, lot # qcmleq were received for evaluation.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the pull force and tensile strength 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.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10472355
• Report Number: 2210968-2020-06527
• Device Sequence Number: 2407469
• Product Code: NEW
• UDI-Device Identifier: 10705031060845
• UDI-Public: 10705031060845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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: 02/28/2025
• Device Model Number: Z398H
• Device Catalogue Number: Z398H
• Device Lot Number: QCMLEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 09/23/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/14/2020; 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1