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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
*** update 02-sep-26: further information was provided that the broken parts were retrieved from the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 the reported event was confirmed as the visual evaluation of the received ar-12990 with batch 10329292 revealed that the moving jaw is broken off (see evaluation pictures 2 + 3).No broken pieces were returned for inspection.A functional test was not performed due to damage to the device.The most likely cause of the reported failure can be attributed to improper use / device handling.Furthermore, the visual evaluation revealed that there are signs of metal surface oxidation on the tip (see evaluation picture 2 + 3).

• Brand Name: Knee Scorpion
• 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: 50520856
• Report Number: 1220246-2026-04551
• Device Sequence Number: 10693707
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: (01)00888867196322(11)190703(10)10329292
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 08/31/2026

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: 10329292
• 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: 08/17/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2019
• 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