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

Catalog Number	Z347H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
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 was met prior to the release of this lot.Attempts are being made to obtain the following information.  to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify if it was a needle breakage or suture pull off in the reported event.Did the suture pull off occur as result of the needle breakage? 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 a patient underwent an unknown surgery procedure in 2018 and a suture was used.During surgery, the suture thread became detached from the needle, and the end of the needle (where the suture attaches) broke off.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/17/2019.Investigation summary: it was reported needle pull off and needle breakage.Four-teen unopened samples of product code z347, 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 z347h sutures.A fracture was observed at the suture attachment of sample a.One side of sample a was received, the mating fracture surface was not provided 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.Additional information was requested and the following was obtained: please clarify if it was a needle breakage or suture pull off in the reported event.- suture pull off, no needle breakage.Did the suture pull off occur as result of the needle breakage? suture pull off, no needle breakage.

• 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: 8125134
• Report Number: 2210968-2018-77452
• Device Sequence Number: 13994755
• 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,Followup
• Report Date (Section B): 11/06/2018

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: 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
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1