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

Model Number	KNEE SCORPION
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
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, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-12990n scorpion needle tip broke.It was reported that during a meniscal root repair surgery a scorpion handpiece was used, and when the stitch was passed through the root, the tip of the root broke.No patient harm was reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-12990 that displays a broken tip on the device.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone preparation and/or prying/leveraging during insertion.

• 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: 24343298
• Report Number: 1220246-2026-00590
• Device Sequence Number: 9541203
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 05/27/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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