MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 3-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z332H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
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.Investigation summary: it was reported performance breakage suture.Ten unopened samples were returned for analysis.During the visual inspection of the ten samples, no defects were found on the packages.The samples were 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, damaged or suture breakage 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 samples, no breakage suture was found on the sutures and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a animal underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture broke while finishing and tying the knot.Another like device was used to complete the procedure.

• Brand Name: PDS II SUTURE 27"(70CM) 3-0 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: 8290037
• Report Number: 2210968-2019-78634
• Device Sequence Number: 14069105
• Product Code: NEW
• UDI-Device Identifier: 10705031060524
• UDI-Public: 10705031060524
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/07/2019

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: 10/31/2022
• Device Catalogue Number: Z332H
• Device Lot Number: LMZ884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/30/2019
• Patient Sequence Number: 1