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

Model Number	KNEE SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2026
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
It was reported that during the repair of a radial posterior meniscus tear, the tip of the needle broke off.The broken piece remained in the patient´s knee.The surgery was finished successfully with a different device (ar-4580).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was not confirmed and one unpackaged ar-12990, knee scorpion, batch number 83609, was received for investigation and the functional testing revealed no problems.The proper function is given (see evaluation pictures 3 + 4).No fragments were returned for evaluation.Upon visual inspection, it was observed that the device shows signs of metal surface oxidation (see evaluation pictures 5 + 6).The most likely cause for the reported failure can be attributed to wear and tear due to the age of the device (manufacturing year 2017).

• Brand Name: KNEE SCORPION
• 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: 24161780
• Report Number: 1220246-2026-00292
• Device Sequence Number: 9112332
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: (01)00888867196322(11)171004(10)83609
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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): 04/21/2026

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: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 83609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown