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	Insufficient Information (4580)
Date of Event	03/12/2026
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 (b)(6) 2026, an arthrex employee reported via email that the ar-12990n scorpion needle, knee batch 15386602 became stuck and subsequently broke inside the knee scorpion suture passer.The issue was identified during a quads acl reconstruction procedure.No piece(s) broke off inside the patient, and the procedure was successfully completed by manually stitching the tendon.

• 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: 24756087
• Report Number: 1220246-2026-01782
• Device Sequence Number: 21027622
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: (01)00888867199354(11)250210(17)300131(10)15386602
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 15386602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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