MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 36"(90CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z347H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: it was reported needle pull off and needle breakage.Four-teen unopened samples of product code (b)(4), lot #: mek771 were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needle breakage was observed.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.Also, the samples were tested by resistance test to needle and met the 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 sample received, no needle pull off or needle breakage were found, and the tested sample met the finished goods requirements.Three failed suture needles were submitted for fractographic evaluation.The components were identified as product code (b)(4) sutures.A fracture was observed at the suture attachment of sample b.Sample b was received in two pieces, only one of the mating fracture surfaces were examined for this evaluation.A microscope was used to examine the fracture surface and surrounding area of the needles.The fracture surface was examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was intergranular, which is evidence of a brittle failure.This was a non-ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was found upon evaluation that the needle was broken at the swage.No adverse patient consequences were reported.

• Brand Name: PDS II SUTURE 36"(90CM) 1 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: 8257751
• Report Number: 2210968-2019-78470
• Device Sequence Number: 2307525
• Product Code: NEW
• UDI-Device Identifier: 10705031060685
• UDI-Public: 10705031060685
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 01/04/2019

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: 04/30/2023
• Device Catalogue Number: Z347H
• Device Lot Number: MEK771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1