MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	661G
Medical Device Problem Code	Break (1069)
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 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 a patient underwent a surgical procedure in (b)(6) 2017 and suture was used for skin closure.During use, the suture snapped.No adverse patient consequences were reported.
Additional Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.No suture, needle or winding former were returned for evaluation to determine the assignable cause of the performance - breakage suture; therefore, the reported failure could not be evaluated.It could not be determined what may have caused the reported incident.

• Brand Name: ETHILON SUTURE 18"(45CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7248522
• Report Number: 2210968-2018-70732
• Device Sequence Number: 19099185
• Product Code: GAR
• UDI-Device Identifier: 10705031007697
• UDI-Public: 10705031007697
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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 Expiration Date: 06/30/2022
• Device Catalogue Number: 661G
• Device Lot Number: LHP525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1