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

Model Number	Z467H
Medical Device Problem Code	Break (1069)
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 pek426 number, and no non-conformances were identified.Device evaluation summary: it was received for analysis an opened box with twenty-two unopened samples of product code z467, lot pek426.The complaint sample was not returned for analysis.During the visual inspection of thirteen 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 representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 4 device issues captured in reports 2210968-2019-91194, 2210968-2019-91196 and 2210968-2019-91197.Analysis results have been included in mw reports for each.
Event or Problem Description
It was reported that the animal underwent an unknown procedure in 2019 and suture was used.The animal experienced wound dehiscence within 3 days after procedure.Post operatively, the suture broke.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/23/2020.Correction: evaluation summary: it was received for analysis an opened box with twenty-two unopened samples of product code z467, lot pek426.The complaint sample was not returned for analysis.During the visual inspection of thirteen 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 representative samples, no performance - breakage suture post-op was found and the tested samples met the finished goods requirements.

• Brand Name: PDSII VIO 27IN 0 S/A CP-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9506245
• Report Number: 2210968-2019-91186
• Device Sequence Number: 1542380
• Product Code: NEW
• UDI-Device Identifier: 10705031061071
• UDI-Public: 10705031061071
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 04/30/2024
• Device Model Number: Z467H
• Device Catalogue Number: Z467H
• Device Lot Number: PEK426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/23/2020
• Patient Sequence Number: 1