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

Model Number	F2415H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 dog underwent suture of a cutaneous wound at the ear and suture was used.While closing of cutaneous wound of the auricular pinna, after 4 tissue passages and 2 simple stitches, the needle pulled off the strand, without any particular force applied on the strand.Another device was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 03/11/2020.A manufacturing record evaluation was performed for the finished device batch pdb671 and no non-conformances were identified.Additional investigation summary: it was received for analysis an empty winding former, a paper lid, and a suture piece of product code f2415h, pdb671.During the visual inspection of the suture piece, not impression at the swage area and the ends damaged(cut) could be observed.In addition, the needle was not return, and we are unable to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the condition of the suture and as the needle was not received, it could not be determined what may have caused the reported incident.Of: ¿needle separation" and the reported complaint was confirmed.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

• 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
• MDR Report Key: 9683108
• Report Number: 2210968-2020-01028
• Device Sequence Number: 11616548
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 03/31/2024
• Device Model Number: F2415H
• Device Catalogue Number: F2415H
• Device Lot Number: PDB671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1