MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation summary: representative samples were returned for evaluation.During the visual inspection, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no suture breakage was found and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the suture broke.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 4-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8499232
• Report Number: 2210968-2019-80192
• Device Sequence Number: 11230334
• Product Code: GAN
• UDI-Device Identifier: 10705031059337
• UDI-Public: 10705031059337
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: Y494G
• Device Lot Number: ML5983
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/10/2019
• Patient Sequence Number: 1