MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 8-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2815G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device for evaluation.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a trans free flap procedure on (b)(6) 2020 and the suture was used.When a doctor was about to anastomose vessel under a microscope, the suture split like a hair down the center of the strand.Another like suture with the same lot number was used to complete procedure successfully without delay.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/27/2020.H3 evaluation: an empty opened box and unopened samples of were received for analysis.The complaint sample was not received.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand with no defects, damages or suture breakages observed.A functional test was performed and the tensile strength force was above the minimum requirement.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 suture breakage was found and the tested samples met the finished goods requirements.

• Brand Name: ETHILON SUTURE 5"(13CM) 8-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9935389
• Report Number: 2210968-2020-02733
• Device Sequence Number: 754597
• Product Code: GAR
• UDI-Device Identifier: 10705031004023
• UDI-Public: 10705031004023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 06/30/2024
• Device Model Number: 2815G
• Device Catalogue Number: 2815G
• Device Lot Number: PHB904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/27/2020
• Patient Sequence Number: 1