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

Catalog Number	1663H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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)? did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? 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 the patient underwent a vascular procedure in (b)(6) 2017 and suture was used for wound closure.During the procedure, the suture from the needle.Suture from a different lot was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: (b)(4) 2018.The actual device was returned for evaluation.During the visual inspection of detached needle (1), the swage and attachment area were as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted and slightly marks were noted on the body needle.The suture was not received for evaluation to determine the assignable cause.No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• 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: 7266981
• Report Number: 2210968-2018-70838
• Device Sequence Number: 16600190
• Product Code: GAR
• UDI-Device Identifier: 10705031001732
• UDI-Public: 10705031001732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/15/2018

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: 1663H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1