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).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: did the needle separated from the suture during use on the patient? or did it separated during handling before use on the patient? during use on the patient.Was the needle found separated from suture inside of the package? no.Did the needle fell inside of the patient? if so, how was it retrieved? yes, was noted at the time of separation and removed immediately.Was the procedure completed successfully? yes.Were there any patient consequences? no.Can you provide the product code? d9541.Procedure name and event date? laparoscopic nessen fundoplication and gastrostomy performed on (b)(6) 2021.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 laparoscopy procedure on (b)(6) 2021 and suture was used.During the procedure, the needle separated from the suture.It is unknown if the device is available for return.No adverse patient consequences were reported.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: 11781342
• Report Number: 2210968-2021-04272
• Device Sequence Number: 845199
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: 04/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1