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

Model Number	SCORPION NEEDLE, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/19/2025, an fda medsun notification was received via email.A facility representative reported that an ar-12990n knee scorpion needle was loaded, and upon deployment by the surgeon, it did not deploy as intended.After removal, it was discovered that the needle had broken off inside the channel of the instrument passer.The needle did not enter the patient, and the broken piece was retrieved.This was discovered during a procedure in (b)(6) of 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 10-dec-2025: this was discovered during a left knee arthroscopy, medial meniscus root repair, and right knee cortisone injection procedure on (b)(6) 2025.The surgery was not delayed, and no additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: b3, b5, g3, h6.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-12990n scorpion needle (batch 14949548) was received for investigation.Visual evaluation confirmed that the tip of the device was fractured.Functional testing could not be performed due to the damaged condition of the device.Dfu-0392-sub-eo includes warnings to help avoid needle breakage and potential patient injury, including precautions regarding the application of excessive force during needle firing.The most likely cause of the reported failure is attributed to user-related factors, specifically excessive force being applied during the firing of the needle.The complaint allegation is confirmed.

• Brand Name: SCORPION NEEDLE, KNEE
• 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: 23745042
• Report Number: 1220246-2025-05492
• Device Sequence Number: 10350080
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: (01)00888867199354(11)220412(17)270331(10)14949548
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N
• Device Lot Number: 14949548
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 03/20/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/05/2026; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown