MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 6-0 D/A RB-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z149H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mkm585 batch number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a pancreatoduodenectomy on (b)(6) 2019 and suture was used.The needle-suture was used for pancreaticojejunostomy by interrupted suturing, but the suture was broken while tying a knot.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/30/2019.It was reported breakage suture.One opened box with unopened samples was received for analysis.The complaint sample was not returned for evaluation.The product code is double armed.During the visual inspection of the 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 breakage suture were observed.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 2 device issues captured in reports 2210968-2019-87187.Analysis results have been included in follow-up reports for each.

• Brand Name: PDSII VIO 30IN 6-0 D/A RB-2
• 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: 9038324
• Report Number: 2210968-2019-87191
• Device Sequence Number: 2516430
• Product Code: NEW
• UDI-Device Identifier: 10705031060289
• UDI-Public: 10705031060289
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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: 08/31/2023
• Device Catalogue Number: Z149H
• Device Lot Number: MKM585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1