MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 sleeve gastrectomy on (b)(6) 2018 and suture was used.During the procedure, the suture snapped performing the knot.Another like device from a different lot number was used to continue with the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/07/2019.Investigation summary: it was reported performance breakage suture.An opened box with nineteen unopened samples were received for analysis.The issue sample was not returned for evaluation.During the inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area were as expected.The sutures were examined along of strand and no defects or breakage suture were noted.Functional test was performed on the samples and the tensile force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance breakage suture were noted and the tested samples met the finished goods requirements.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 0 GRN
• 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: 8105762
• Report Number: 2210968-2018-77343
• Device Sequence Number: 2266739
• Product Code: GAT
• UDI-Device Identifier: 10705031058064
• UDI-Public: 10705031058064
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/30/2018

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: 05/31/2023
• Device Catalogue Number: X834H
• Device Lot Number: MGJ570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1