MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z452G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: was any quality deficiency/non-conformance noted with the sutures before use, during use, during post-op examination or during re-operation if performed? from what we were told in the necropsy notes, the knot was intact.Dr.(b)(6) had reported the suture did break a few times, but this is not unusual for her.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.Note: events reported via: 2210968-2021-05978, 2210968-2021-05979, 2210968-2021-05981, and 2210968-2021-05982.
Event or Problem Description
It was reported that an animal underwent a canine ovariohysterectomy procedure on (b)(6) 2021 and suture was used.Post-operatively, the suture broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 08/05/2021.H6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.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-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12105128
• Report Number: 2210968-2021-05980
• Device Sequence Number: 11603532
• Product Code: NEW
• UDI-Device Identifier: 10705031218703
• UDI-Public: 10705031218703
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 11/30/2025
• Device Model Number: Z452G
• Device Catalogue Number: Z452G
• Device Lot Number: QPMEZU
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1