MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 36IN(90CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F2415H
Medical Device Problem Code	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.Additional information was requested and the following was obtained: did 2 sutures had the issue in 1 procedure? two units (sutures) are implicated for the this procedure.One unit is implicated for another/2nd procedure (captured separately).When did the needles pull off in the package/during dispensing/ during use on patient (suturing)? during use on animal when performing the cutaneous suture.Specific number of procedures in which the needles pulled off, during (b)(6) 2018.Two procedures during (b)(6).No further information available.Attempts have been 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 an animal underwent an unknown procedure on an unknown date and suture was used.Needles from the same box pulled off.No further information available.No patient consequences reported.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Unopened samples of product code were returned for analysis.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area of the needles were as expected.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.The manufacturing records were reviewed and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no attachment defects were found, and the tested samples met the finished goods requirements,.

• Brand Name: ETHILON SUTURE 36IN(90CM) 3-0 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: 7906075
• Report Number: 2210968-2018-75985
• Device Sequence Number: 1692987
• Product Code: GAR
• UDI-Device Identifier: 10705031238930
• UDI-Public: 10705031238930
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 04/30/2022
• Device Catalogue Number: F2415H
• Device Lot Number: LEH029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/23/2018
• Patient Sequence Number: 1