MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number SCORPION-MULTIFIRE NEEDLE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 03/06/2024, an fda medwatch notification was received via email.A facility representative reported that an ar-13995n multifire scorpion needle was opened to the sterile field.Needle was intact and loaded into the scorpion device.Doctor used the scorpion arthroscopically to pass suture through the rotator cuff.The scorpion was passed back to the scrub nurse.The scrub nurse inspected the needle.The needle was intact and passed back to doctor to make another suture pass in the rotator cuff.When the needle was passed back to the scrub nurse, the scrub nurse informed the doctor that the tip of the scorpion needle was not intact.Doctor searched the surgery site with the arthroscope.No fragment of the needle was found.This was discovered during a left shoulder arthroscopy with rotator cuff repair.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18943921
• MDR Text Key: 338156385
• Report Number: 1220246-2024-01579
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 15104524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1