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

Catalog Number	Z968H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number pcz343, and no non-conformances related to the reported complaint condition were identified.Investigation summary: unopened samples of product code z968, lot pcz343 were returned for analysis.During the visual inspection of 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.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, no pull off suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported by a veterinarian that an animal underwent an unknown procedure on an unknown date and suture was used.The suture was separating from the needle while suturing tissue, unknown layer, interrupted loop.Additional suture from the same box was used to complete the procedure.

• 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 0151
• MDR Report Key: 8958097
• Report Number: 2210968-2019-86522
• Device Sequence Number: 2559787
• Product Code: NEW
• UDI-Device Identifier: 10705031061934
• UDI-Public: 10705031061934
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: 02/29/2024
• Device Catalogue Number: Z968H
• Device Lot Number: PCZ343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/03/2019
• Patient Sequence Number: 1