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

Catalog Number	F2417H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.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.Confirm the specific number of devices (total qty actually involved with reported issue), that failed during this one event report/procedure? please confirm the specific number of patient events.Have any of these events been previously reported to ethicon? if yes, please provide complaint file number/ affiliate number.For each patient event please provide additional complaint details: event date, product code and lot number involved, procedure, event description, qty involved? was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed, was procedure completed successfully and how? any sample return, etc? events reported via mw 2210968-2019-82937, 2210968-2019-82938.
Event or Problem Description
It was reported by a veterinarian that an animal underwent an unknown procedure on an unknown date and suture was used.The needle pulled off from the thread after a few tissue passages, without exerting excessive tension on the thread.Another device was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch paj121, f2417h55 and no non-conformances were identified.Additional investigation summary: it was received for analysis unopened samples of product code f2417, lot paj121.The complaint sample was not received for evaluation.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 to be 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 condition of the samples, no pull off suture needle was 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: 8712452
• Report Number: 2210968-2019-82937
• Device Sequence Number: 2247135
• Product Code: GAR
• UDI-Device Identifier: 10705031238954
• UDI-Public: 10705031238954
• 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): 05/24/2019

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: 12/31/2023
• Device Catalogue Number: F2417H
• Device Lot Number: PAJ121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1