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

Catalog Number	Y493G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the total number of procedures, where the needle disengaged from the swage, while the surgeon was closing the wound? for each patient procedure, where the needle disengaged from the swage, please provide the following information: procedure name and date.Product code(s) and lot number(s) of the device(s) where the needle pulled off at the swage.Were there any adverse patient consequences? if so, please clarify any surgical or medical intervention.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? have any of these events been previously reported to ethicon? if so, please provide the respective reference number(s).
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle disengaged from the swage while the surgeon was closing the wound.It was unknown how the procedures 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: 7263253
• Report Number: 2210968-2018-70799
• Device Sequence Number: 13699882
• Product Code: GAN
• UDI-Device Identifier: 10705031059313
• UDI-Public: 10705031059313
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• 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): 01/25/2018

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: 09/30/2022
• Device Catalogue Number: Y493G
• Device Lot Number: LLZ025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1