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

Catalog Number AR-13995N

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

Tip of scorpion needle broke off inside patient's shoulder.Was able to locate the needle and in the process of trying to retrieve it, it moved.Needle was never located again.Shoulder pouch and neptune filter looked at to see if it was there at the end of the case.It was not.Surgeon declined to do an x-ray.

• Brand Name: 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: 14521789
• MDR Text Key: 292815903
• Report Number: 14521789
• 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: 05/17/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-13995N
• Device Lot Number: 14034643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• 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: 21535 DA
• Patient Sex: Male