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
An unopened representative sample was returned for evaluation.During the visual inspection of sample, no defects were found on the package.The sample was opened and the swage and attachment area were as expected.The suture was dispensed without problems and examined along of the strand and no defects or suture breakage were observed.In addition, the sample was tested by tensile strength and the result is above the minimum individual strength requirement.Per the condition of the representative sample, no performance - breakage suture was observed and the sample tested met the finished good requirements.

• 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: 7248524
• Report Number: 2210968-2018-70730
• Device Sequence Number: 11017323
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• 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