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

Catalog Number	Y740D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: the needles weren¿t actually popping off.They said that when tying the knots the suture itself was breaking.It wasn¿t breaking off where expected with normal control release sutures but in different areas of the strand.It was not happening at the knot but along the strand as they were tying.The tech noted they didn¿t break in a clean manner, such as if they were cut.She said you could almost notice it was sort of frayed where they broke.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? no needles fell off inside the patient.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Event or Problem Description
It was reported that the patient underwent an abdominal hysterectomy on (b)(6) 2018 and suture was used.During the procedure, the suture broke.Another suture was used to complete the procedure.There were no patient consequences.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 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: 7450943
• Report Number: 2210968-2018-72275
• Device Sequence Number: 1607746
• Product Code: GAN
• UDI-Device Identifier: 10705031059559
• UDI-Public: 10705031059559
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• 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): 03/28/2018

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: Y740D
• Device Lot Number: LK6868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1