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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 a surgery the instrument ar-12990 (lot: 15333400) was used for the first time with a new ar-12990n needle, but during the operation the needle in the instrument broke.All fragments were removed, but the instrument did not work.Per complaint reporter there was no harm for patient, operator or third party.No further information received.Update avoe 08-dec-2025 it was confirmed that the error occurred during a meniscus suturing inside-out surgery.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Corrected information: e1 country corrected to slovenia.Additional information: g3, h3, h6.The reported event was confirmed as one unpackaged ar-12990n was received inside an ar-12990 knee scorpion batch number 15333400 for investigation.The device investigated was the ar-12990 knee scorpion.Functional testing was performed on the returned ar-12990 with an ar-12990n, and it was found that the needle could not be fully inserted (see evaluation picture 3).The ar-12990n was met with resistance and could not pass through the shaft of the device.The most likely cause of the reported failure is user error in the device.Excessive force was used during the firing of the needle, breaking the needle and causing a blockage within the shaft.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-12990n was received inside an ar-12990 knee scorpion batch number 15333400 for investigation.The device investigated was the ar-12990 knee scorpion.Functional testing was performed on the returned ar-12990 with an ar-12990n, and it was found that the needle could not be fully inserted (see evaluation picture 3).The ar-12990n was met with resistance and could not pass through the shaft of the device.The most likely cause of the reported failure is user error in the device.Excessive force was used during the firing of the needle, breaking the needle and causing a blockage within the shaft.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.

• 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: 23769823
• Report Number: 1220246-2025-05555
• Device Sequence Number: 9742771
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: 00888867199354
• 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,Followup
• Report Date (Section B): 03/03/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/27/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/11/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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