MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 36IN(90CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F2414H
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).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.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 a patient underwent an unknown procedure on an unknown date and suture was used.The needle pulled away from the thread.After knotting, the thread broke.No further information available.No patient consequence reported.The device is not available for analysis.
Additional Manufacturer Narrative
(b)(4).Additional device evaluated by mfr: it was received for analysis unopened samples of product code f2414.Lot mmh531.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along of the strand and no defects or suture breakage were noted.Functional test was performed and the pull force and 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 breakage suture, surface related defect -suture and pull off suture needle were observed, and the tested sample meet the finished goods requirements.

• Brand Name: ETHILON SUTURE 36IN(90CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8540156
• Report Number: 2210968-2019-80611
• Device Sequence Number: 11198521
• Product Code: GAR
• UDI-Device Identifier: 10705031238923
• UDI-Public: 10705031238923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 10/31/2023
• Device Catalogue Number: F2414H
• Device Lot Number: MMH531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1