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	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/07/2026
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 11th april 2026, it was reported by an arthrex's employee via an email that 2 units of ar-12990n, scorpion¿ needle, knee, were broken when the surgeon tried very hard to pass a suture through the meniscus root.The patient's knee was super small and super tight.When the needle passed through the meniscus root, the needle tip hit the femur bone and broke.This was detected during a right knee meniscus root repair and centralisation procedure on (b)(6) 2026.The procedure was completed successfully.Additional information received on 14th april 2026: however, the broken pieces were not retrieved from the patient.As it fell to the back of the knee, surgeon dare not anyhow poke as there's vascular bundles.

• 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: 24999217
• Report Number: 1220246-2026-02463
• Device Sequence Number: 8750423
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: (01)00888867199354(11)251110(17)301031(10)15528155
• 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): 05/06/2026

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: 15528155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown