MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE

Model Number AR13995N

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2018

Event Type  malfunction  

Event Description

During a shoulder arthroscopy the point of the scorpion needle broke off.X-ray revealed a 2mm foreign body.Scorpion needle examined and compared to another.Tip of needle is missing.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.

• Brand Name: SCORPION NEEDLE
• Type of Device: SCORPION NEEDLE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108 1945
• MDR Report Key: 7482422
• MDR Text Key: 107346561
• Report Number: MW5076979
• Device Sequence Number: 0
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR13995N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR