MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 2 S/A TP-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	D7190
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 lot, and no non-conformances were identified.Summary: two opened boxes with thirteen and eleven unopened representative samples were received for evaluation.This product code is double armed.During the visual inspection of samples, no defects were found on the package.The samples were opened, and 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 observed.A functional test was performed, and the pull force was above the minimum requirements.Additionally, the tensile strength force was above the minimum requirement.Per the conditions of the sample received, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and the suture was used.It was reported that the suture was removed from the packet and it broke in half.Another like suture was used.There were no patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 01/23/2020.Corrected h-3 summary: two opened boxes with thirteen and eleven unopened representative samples were received for evaluation.This product code is double armed.During the visual inspection of samples, no defects were found on the package.The samples were opened, and 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 observed.A functional test was performed, and the pull force was above the minimum requirements.Additionally, the tensile strength force was above the minimum requirement.Per the conditions of the sample received, the tested sample met the finished goods requirements.

• Brand Name: PDSII VIO 60IN 2 S/A TP-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: 9621812
• Report Number: 2210968-2020-00612
• Device Sequence Number: 13578908
• Product Code: NEW
• UDI-Device Identifier: 10705031027350
• UDI-Public: 10705031027350
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 01/03/2020

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: 12/31/2023
• Device Model Number: D7190
• Device Catalogue Number: D7190
• Device Lot Number: PAZ177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 01/23/2020
• Patient Sequence Number: 1