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

Model Number	SUREFIRE SCORPION NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 1//13/2025, it was reported by a facility representative via email that an ar-13991n surefire scorpion needle broke inside the patient.This was discovered during a procedure.No further information was provided.Additional information requested on 1/23/2025: this was discovered during a left shoulder arthroscopy with an rcr procedure on (b)(6)2025.The needle broke into fragments inside the patient's shoulder, and unsuccessful attempts were made to retrieve the fragments.The ar-13991n surefire scorpion needle was used with an ar-13997sf when it broke.The fastpass scorpion did not malfunction or experience damage.The case was delayed thirty minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, including excessive force to pass the needle through fibrous/calcific tissue.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: SUREFIRE SCORPION NEEDLE
• Common Device Name: 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: 21320546
• Report Number: 1220246-2025-00228
• Device Sequence Number: 18317129
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: (01)00888867015920(11)241014(17)290930(10)15331441
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 15331441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown