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

Catalog Number	Z317H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance fraying suture intra-op.Two sealed boxes and an opened box with twenty one unopened samples of product code z317, lot # pck398 were received for evaluation.The complaint sample was not received.During the visual inspection of thirteen representative sample, no defects were found on the packages.The samples were opened and contain a strand per packet.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or fraying suture was observed.A tactile test was performed to strands and no unraveling or fraying could be detected.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection of the samples received no performance fraying suture intra-op were observed.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-85508 and 2210968-2019-85509.Analysis results have been included in reports for each.
Event or Problem Description
It was reported that an animal underwent an unknown veterinary procedure on an unknown date and suture was used.During the procedure, the suture was unraveling.It is unknown how the case was completed.

• Brand Name: PDSII VIO 27IN 2-0 S/A SH
• 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: 8890761
• Report Number: 2210968-2019-85509
• Device Sequence Number: 11532943
• Product Code: NEW
• UDI-Device Identifier: 10705031060494
• UDI-Public: 10705031060494
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: Z317H
• Device Lot Number: PCK398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1