MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 5-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y493G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional evaluation summary: the actual sample was returned for evaluation.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole was examined and remnant suture was noted.The suture end is severely cut (damaged), resulting in a clip off defect.Per the sample condition the assignable cause is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Additional information was requested and the following was obtained: clarify how many sutures were found broken when opening up the package? clarify how many sutures were found separated from the needle? please confirm when the issue occurred (while in the package, during dispensing, during use) what is the product code and lot number? for the 5-0 fast sutures, the surgeon goes to make his first pass with the suture and the needle immediately pulls apart from the suture.This has happened at least once a month, so over multiple lots.It is usually one suture per box of 12.The sutures are in tact when they are opened and dropped, but break apart after the first pass.The product code is ety493g and the lot number is mgm391.The single complaint was reported with multiple events.There are no additional details regarding the additional events.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure the suture had broken and the needle came off the suture.The surgeon goes to make his first pass with the suture and the needle immediately pulls apart from the suture.The sutures are intact when they are opened and dropped, but break apart after the first pass.It was unknown how the procedure was completed.There were no patient consequences reported.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 5-0 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: 8449794
• Report Number: 2210968-2019-79647
• Device Sequence Number: 14217316
• Product Code: GAN
• UDI-Device Identifier: 10705031059313
• UDI-Public: 10705031059313
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 05/31/2023
• Device Catalogue Number: Y493G
• Device Lot Number: MGM391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1