MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXC GRN 36IN 2-0 D/A MH; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X843H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
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.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.Was the needle removed from the patient? was the needle removed during the same procedure? was there any additional tissue damage as a result of searching for the needle? how long was the surgery prolonged to allow removal of the needle? did the patients post op care change (i.E.Additional antibiotics, prolonged hospitalization, additional post op surgery) as a result of enlargening the surgery cut or as a result of prolonged surgery or intervention time, if applicable? patient demographics (initials/id, age or date of birth, weight, gender) will any representative samples be returned for evaluation? lot number; patient's demographics.Was any intervention provided to the surgeon due to the needle stick on the finger?.
Event or Problem Description
It was reported that a patient underwent an aortic valve replacement and repair of ascending aortic aneurysm on (b)(6) 2018 and suture was used.While the surgeon was suturing in the graft, the needle popped off of the suture and was lost inside the aorta.It was later found when the needle stuck the surgeon in his finger as he was feeling the backside of the aorta with his finger.It is unknown how the case was completed.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Additional information was requested and the following was obtained: 1-was the needle removed from the patient? -yes 2-was the needle removed during the same procedure? -yes 3-was there any additional tissue damage as a result of searching for the needle? -not to the patient 4-how long was the surgery prolonged to allow removal of the needle? -30 minutes 5-did the patients post op care change (i.E.Additional antibiotics, prolonged hospitalization, additional post op surgery) as a result of enlarging the surgery cut or as a result of prolonged surgery or intervention time, if applicable? - no 6-patient demographics (initials/id, age or date of birth, weight, gender) : (b)(4).7-will any representative samples be returned for evaluation? - no 8-lot number? -unknown 9-was any intervention provided to the surgeon due to the needle stick on the finger? -no.

• Brand Name: ETHIBOND EXC GRN 36IN 2-0 D/A MH
• 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: 7826796
• Report Number: 2210968-2018-75527
• Device Sequence Number: 16465427
• Product Code: GAT
• UDI-Device Identifier: 10705031058088
• UDI-Public: 10705031058088
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: X843H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1
• Patient Age: 58 YR