MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2892G
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure: no information.Date and name of index surgical procedure: (b)(6) 2018.The diagnosis and indication for the index surgical procedure?: no information.Did the needle break or did the needle pull off from the suture? is the entire needle retained or a portion of the needle? what is the size of the piece of needle that remained in patient¿s tissue? where is the retained piece located, in what structure? was the retained needle noticed during the initial procedure? were there any attempts to remove the needle during the initial procedure?: the needle wasn't broken.A nurse realized that there was no needle after the operation, but they couldn't find the needle.Were x-rays performed to localize the needle fragment?: no information.Are there any plans to remove the retained needle?: no information.What instruments were used to grasp the needle?: no information.Where was the needle grasped during use?: no information.Any patient consequences?: no information.What is physician¿s opinion as to the etiology of or contributing factors to the event?: no information.What is the patient¿s current status?: no information.".
Event or Problem Description
It was reported that the patient underwent unknown neurosurgery on (b)(6) 2018 and suture was used.The needle was not broken but remained inside the brain.A nurse realized that there was no needle after the operation, but they couldn't find the needle.Additional information has been requested.

• Brand Name: ETHILON SUTURE 5"(13CM) 10-0 BLK
• 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: 7524112
• Report Number: 2210968-2018-72881
• Device Sequence Number: 16503633
• Product Code: GAR
• UDI-Device Identifier: 10705031004252
• UDI-Public: 10705031004252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 2892G
• Device Lot Number: JGK765
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention