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	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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? note: events reported via mw 2210968-2019-82937.
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.

• 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: 8712451
• Report Number: 2210968-2019-82938
• Device Sequence Number: 2274347
• 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
• 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 Catalogue Number: F2417H
• Device Lot Number: PAJ121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1