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

Model Number AR-13995N

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

The surgeon was using the scorpion needle to pass suture from the anchor through the rotator cuff to complete the repair.After deploying the needle through the rotator cuff, the surgeon immediately noticed the tip of the needle was missing.The surgeon obtained intra-operative x-rays and determined the tip could not be safely removed without causing more damage to the patient's rotator cuff and surrounding structures.

• Brand Name: ARTHREX SCORPION-MULTIFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 17297347
• MDR Text Key: 318754954
• Report Number: 17297347
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-13995N
• Device Lot Number: 15076211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA
• Patient Sex: Male