MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	F2413H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Additional information was requested and the following was obtained: please provide procedure name and date: procedure name: handle surgery.Please explain how was procedure completed: use of another device to complete the procedure.Please clarify if there were any adverse patient consequences due to this suture pull of? no patient consequence, but non evaluation of tissue's risk.The lot number is: ethilon 5-0 lot : rbbaha.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a handle surgery on an unknown date in 2021 and suture was used.During the procedure, the suture pulled off of the needle.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: ETHILON SUTURE 30IN(75CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12166387
• Report Number: 2210968-2021-06328
• Device Sequence Number: 19898471
• Product Code: GAR
• UDI-Device Identifier: 10705031238916
• UDI-Public: 10705031238916
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 01/31/2026
• Device Model Number: F2413H
• Device Catalogue Number: F2413H
• Device Lot Number: RBBAHA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1