MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X872H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
It was reported that an animal underwent a procedure to create a pouch intra muscular on (b)(6) 2019 and suture was used.Post- operatively the suture was observed to have created entrapment of the bowel, and the suture was spit and appeared cut.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 GRN
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8465744
• Report Number: 2210968-2019-79817
• Device Sequence Number: 16900718
• Product Code: GAT
• UDI-Device Identifier: 10705031058187
• UDI-Public: 10705031058187
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 07/31/2022
• Device Catalogue Number: X872H
• Device Lot Number: LJJ885
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1