MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 18"(45CM) 4-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z773D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a caesarean section on (b)(6) 2018 and suture was used.During the procedure, the suture broke other than knots when tying a knot during dermostitch by interrupted suturing.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018 an unopened sample of product was returned for analysis.The product code is control release.The issued sample was not received for evaluation.During the visual inspection of the sample, no defects were found on the packages.The sample was opened and the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects were observed.A functional test was performed and the tensile force were 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 sample, no performance - breakage suture was found on the suture and the tested sample met the finished goods requirements.

• Brand Name: PDS II SUTURE 18"(45CM) 4-0 VIO
• 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: 7569440
• Report Number: 2210968-2018-73301
• Device Sequence Number: 18883324
• Product Code: NEW
• UDI-Device Identifier: 10705031061712
• UDI-Public: 10705031061712
• 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): 05/09/2018

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: 08/31/2022
• Device Catalogue Number: Z773D
• Device Lot Number: LK6531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1