MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 18"(45CM) 0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	CX45D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported: suture breakage.A winding former with six needle-suture combinations and a paper lid of product code cx45d were returned for analysis.The issue samples were not received for evaluation.During the visual inspection of the five needle-suture combination, the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile force were above the minimum requirements.The dhr review could not be conducted, because the batch number of the complaint is unknown.Per the condition of the representative samples, no suture breakage was found on the sutures and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent a umbilical hernia repair procedure on (b)(6) 2019 and suture was used.During the procedure, the suture snapped while tying the knot but the surgeon was able to complete the procedure with this suture.There were no patient consequences reported.

• Brand Name: ETHIBOND EXCEL SUTURE 18"(45CM) 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: 8335778
• Report Number: 2210968-2019-78845
• Device Sequence Number: 13832150
• Product Code: GAT
• UDI-Device Identifier: 10705031024304
• UDI-Public: 10705031024304
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 01/17/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CX45D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/13/2019
• Patient Sequence Number: 1