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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 27-aug-2026, it was reported by a sales representative via sems-(b)(6) that an ar-12990n scorpion needle became jammed in the tip of the knee scorpion shaft after firing, and the tip of the scorpion needle broke off when removed from the scorpion.And an ar-1594d-24 drill and passing wire stylets on the back of both pins broke when being screwed back in to clear bony debris.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Scorpion Needle, Knee
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50771175
• Report Number: 1220246-2026-04719
• Device Sequence Number: 16063758
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: (01)00888867199354(11)251229(17)301130(10)15550481
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 15550481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown