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

Model Number	Z968H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot phk348, and no non-conformances were identified.Investigation summary: it was received for analysis an opened box with unopened sample of product code z968h, lot phk348.During the visual inspection of the 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 tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples received, no performance - breakage suture was found and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that an animal underwent a spay procedure on (b)(6) 2020 and suture was used.During the procedure, the doctor was suturing tissue and the suture was cork screwing and breaking in the middle of the strand, unknown tissue layer, unknown loop.Another like device was used.No consequences to the animal.

• Brand Name: PDSII VIO 27IN 3-0 S/A CP-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: 9871713
• Report Number: 2210968-2020-02301
• Device Sequence Number: 19560808
• Product Code: NEW
• UDI-Device Identifier: 10705031061934
• UDI-Public: 10705031061934
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: 06/30/2024
• Device Model Number: Z968H
• Device Catalogue Number: Z968H
• Device Lot Number: PHK348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1