MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 48"(122CM) 2-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9464
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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.
Event or Problem Description
It was reported that the patient underwent an esophagectomy on an unknown date and suture was used.During the procedure, the surgeon was passing the suture and the needle broke off inside the patient.No x-rays were needed and the needle was successfully retrieved laparoscopically during the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Investigation summary a failed suture needle was submitted for evaluation.A fracture was not observed on the needle.The evaluation revealed the needle was not fractured.The surfaces were examined in multiple locations in order to confirm no fracture occurred.

• Brand Name: ETHIBOND EXCEL SUTURE 48"(122CM) 2-0 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: 7677516
• Report Number: 2210968-2018-74235
• Device Sequence Number: 1369694
• Product Code: GAT
• UDI-Device Identifier: 10705031033207
• UDI-Public: 10705031033207
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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 Catalogue Number: D9464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/21/2018
• Patient Sequence Number: 1