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	Foreign Body In Patient (2687)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The manufacturing record evaluation was performed and identified a non-conformance, which was raised to address the event reported.The necessary actions have been taken to address the issue.The final quality release criteria were met before this batch was released for distribution.Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? how was the needle grasped and how was control lost of the needle? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? if device is available for return, please provide: return date and tracking information? can you provide a copy of voluntary medwatch report for this case or report number?.
Event or Problem Description
It was reported that the patient underwent a laparoscopic nissen fundoplication with gastrostomy on (b)(6) 2021 and the suture was used.During use on the patient, the needle detached from the suture and fell inside the patient.It was not detected immediately or with post-procedure count, but it was found on subsequent x-ray.The patient was returned to or on (b)(6) 2021 and the needle was retrieved successfully in laparoscopic removal procedure.Additional information has been 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: 11825273
• Report Number: 2210968-2021-04638
• Device Sequence Number: 3535390
• 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): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention