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	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/26/2025, an fda medsun notification was received via email.A facility representative reported that the tip of the needle from an ar-12990n scorpion needle broke during a procedure performed in (b)(6) 2025.The broken piece was retrieved, and no x-ray was required, according to the attending physician.Additional information was received on 12/05/2025: this occurred on (b)(6) 2025 during a procedure, and no patient harm was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received on 12/19/2025 from the sales representative present at the procedure: this occurred during a quadriceps tendon acl reconstruction; the tip of an ar-12990n scorpion needle broke while closing the quad tendon defect.The detached fragment was located outside the patient by the surgical technician.The broken tip and remaining shaft were compared to an intact needle, confirming that all components were accounted for and removed from the surgical field.The procedure was completed using a non-arthrex product.The case experienced an approximate five-minute delay; no additional anesthesia was administered.No adverse patient effects were reported during or after surgery.Additional information was received on 12/24/2025: the ar-12990 knee scorpion was used with the ar-12990n scorpion needle during this event.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause of the reported failure is user-related, such as excessive force during needle firing.Dfu-0392-sub-eo warns against the listed uses to help prevent 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: 23838656
• Report Number: 1220246-2025-05684
• Device Sequence Number: 18596149
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: (01)00888867199354(11)250804(17)300731(10)15476962
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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
• Device Lot Number: 15476962
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 04/02/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/16/2026; 04/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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