MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	663G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.When did the needle pull off (while in the package / during dispensing / during preparation / during use)? were any attempts made to retrieve the broken piece? if so, was there any additional tissue damage as a result of searching for the needle piece? was the patient brought back to or to attempt retrieving the needle or was it during the initial procedure? were x-rays taken to locate the needle piece(s)? at what location was the needle found? what tissue structure is the needle located? if retained, what is the surgeon's opinion of consequences to the patient? what in the physicians opinion are the factors contributing to the event?.
Event or Problem Description
It was reported that a patient underwent a skin closure in (b)(6) 2018 and suture was used.During the procedure, the needle completely separated from the thread.The thread did not break and the needle remained in the patient¿s skin.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: (b)(4) 2018.Additional information was requested and the following was obtained: when did the needle pull off (while in the package / during dispensing / during preparation / during use)? during use.2.Were any attempts made to retrieve the broken piece? yes.A.Was there any additional tissue damage as a result of searching for the needle piece? no.B.Was the patient brought back to or to attempt retrieving the needle or was it during the initial procedure? it occurred during procedure.3.Were x-rays taken to locate the needle piece(s)? no a.At what location was the needle found? in the dermis 4.What tissue structure is the needle located? skin 5.If retained, what is the surgeon's opinion of consequences to the patient? not retained 6.What in the physicians opinion are the factors contributing to the event? the suture separated from the thread.The needle was visible in the wound and easily removed.No obvious reason for this to happen.

• Brand Name: ETHILON SUTURE 18"(45CM) 3-0 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: 7264521
• Report Number: 2210968-2018-70816
• Device Sequence Number: 11196727
• Product Code: GAR
• UDI-Device Identifier: 10705031007772
• UDI-Public: 10705031007772
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 01/29/2018

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: 663G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1