MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 3X30IN 2-0 S/A TF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	D9541
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to retrieve the device.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: what tissue/location was suturing when pull-off occurred? posterior vagus.Were there any unexpected outcomes or complications as a result of this suture needle pull-off event? no.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This medwatch report is in response to receipt of maude event report mw5100781.
Event or Problem Description
It was reported that a patient underwent a laparoscopic nissen fundoplication and gastrostomy procedure on (b)(6) 2021 and suture was used.During the procedure, the suture and needle separated.It was immediately retrieved with no patient injury.Additional information was requested.

• Brand Name: EB EXC GRN 3X30IN 2-0 S/A TF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11888887
• Report Number: 2210968-2021-05014
• Device Sequence Number: 14265144
• Product Code: GAT
• UDI-Device Identifier: 10705031033481
• UDI-Public: 10705031033481
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 12/31/2024
• Device Model Number: D9541
• Device Catalogue Number: D9541
• Device Lot Number: QAMLLA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1