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	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that a patient underwent gyn procedure on (b)(6) 2018 and suture was used.The suture broke when the surgeon pulled the suture through tissue a different type of suture was used to complete the procedure.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.A paper lid, a winding former with three re-parked needles from slot # 1 to 3 and 8, four needle/suture combinations form slot # 4 to 7 of product code (b)(4) were returned for analysis.This product code requires 8 strands per packet.During the visual inspection of sample, the swage and attachment area were as expected.Also, needle/suture combinations and suture pieces have begun with the process of disintegration, since the sutures were breakage in several sections.The product code (b)(4) contains an absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.In addition, the foil was not returned for evaluation to determine if any damaged was present, that could be attributable to degradation of the suture.Due to foil was not received for evaluation, no conclusion could be reached as to what may have caused the reported incident, the assignable cause of the reported complaint could not be determined.Representative samples were returned for evaluation.During the visual inspection of the samples, no defects were found on the packages.Samples were opened and 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 were observed.A functional test was performed and the tensile force were above the minimum requirements.Per the condition of the representative samples, no performance - breakage suture was found on the sutures and the tested sample met the finished goods requirements.

• 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: 7560374
• Report Number: 2210968-2018-73202
• Device Sequence Number: 16187091
• 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,Followup
• Report Date (Section B): 05/07/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1