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

Model Number SUREFIRE SCORPION NEEDLE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2023

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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during surgery the surgeon did not succeeded to use the scorpion device correctly and another one was used.The next day after surgery, few fragments were seen on the x-ray inside of the joint.No further information received.***update avoe 07-nov-2023: it was further reported that the surefire¿ scorpion¿ needle ar-13991n (lot: 15062341) was used with the reported scorpion device.It is unclear if the fragments came from the scorpion or the needle.***update avoe 16-nov-2023: it was confirmed that for the moment no second surgery is planned to remove the fragments.

• Brand Name: SUREFIRE SCORPION 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: emily shafer ; 8009337001
• MDR Report Key: 18228949
• MDR Text Key: 330457430
• Report Number: 1220246-2023-08976
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: 00888867015920
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 15062341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2023
• 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