MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 27IN USP1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP325H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional evaluation summary: twenty-eight samples of product code pdp325, lot mgk006 were returned for evaluation.During the visual inspection, 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 suture breakage was found and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.It was reported that the suture broke close to the needle.An alternative product was used to complete the procedure.There were no patient consequence and no delay of the procedure,.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mgk006 batch number, and no non-conformances were identified.

• Brand Name: PDS PLUS VIO 27IN USP1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9210870
• Report Number: 2210968-2019-88841
• Device Sequence Number: 13529315
• Product Code: NEW
• UDI-Device Identifier: 10705031048140
• UDI-Public: 10705031048140
• Combination Product (Y/N): N
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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: No Information
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: PDP325H
• Device Lot Number: MGK006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/14/2019
• Patient Sequence Number: 1