MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 2-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z969H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: representative samples returned to support investigation of multiple device issues captured in reports 2210968-2018-77428, 2210968-2018-77431, 2210968-2018-77432, 2210968-2018-77433.Analysis results have been included in reports for each.Ten unopened samples of product were returned for analysis.During the visual inspection of ten samples, no defects were found on the packages.The samples were opened, and the swage and attachment area of the needles were as expected.The sutures were dispensed without problems and examined along the strands with no defects observed.A functional test was performed and the pull force was 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 conditions of the samples received, no attachment defects were found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that an animal underwent a spay procedure on (b)(6) 2018 and a suture was used.During surgery, the suture kept breaking off the needle while surgeon was tightening the stitches.A replacement device was used to complete the procedure.There were no adverse consequences reported.No additional information was provided.

• Brand Name: PDS II SUTURE 27"(70CM) 2-0 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: 8122916
• Report Number: 2210968-2018-77433
• Device Sequence Number: 19143389
• Product Code: NEW
• UDI-Device Identifier: 10705031061941
• UDI-Public: 10705031061941
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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: 07/31/2019
• Device Catalogue Number: Z969H
• Device Lot Number: JAZ547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 12/01/2018
• Patient Sequence Number: 1