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

Catalog Number	Z452G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Evaluation: the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An opened box and unopened samples of product were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile force was 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 representative samples, no suture breakage was found on the sutures and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that an animal underwent a cat spaying procedure on (b)(6) 2018 and a suture was used.After surgery, the animal was x-rayed and found that the suture had broken in the middle.The knots were intact but the middle of the suture line was broken.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-1
• 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: 8073936
• Report Number: 2210968-2018-77111
• Device Sequence Number: 19265709
• Product Code: NEW
• UDI-Device Identifier: 10705031218703
• UDI-Public: 10705031218703
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/18/2018

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: 02/28/2023
• Device Catalogue Number: Z452G
• Device Lot Number: MC5014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1