MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y345H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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 during an unknown procedure in 2018, suture was used.It was reported that the suture broke at 1 to 3 cm from needle when in use.Another suture was used to complete the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
Representative samples were returned for evaluation.During the visual inspection of the unopened samples 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 strands and no defects were observed.Functional test was performed on the samples using a instron and tensile strength force were above the requirements.No actual suture or needle were returned for evaluation to determine the assignable cause of the performance breakage suture; therefore, the reported failure could not be evaluated.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 2-0 VIO
• 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: 7472415
• Report Number: 2210968-2018-72445
• Device Sequence Number: 1215889
• Product Code: GAN
• UDI-Device Identifier: 10705031058897
• UDI-Public: 10705031058897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960653
• 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): 04/05/2018

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: 08/31/2022
• Device Catalogue Number: Y345H
• Device Lot Number: LKM788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1