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	01/14/2026
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 employee via email that ar-12990n scorpion needle, knee batch 15476962 needle tip broke in patient's knee during a procedure on (b)(6) 2026.This was detected when the attending representative attempted to load the suture onto the scorpion needle on (b)(6) 2026.The fragment was removed from the patient, and the acl reconstruction and meniscus root repair were completed successfully.No harm to patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed by the attached picture, which shows that the needle tip was broken off.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 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: 24257161
• Report Number: 1220246-2026-00393
• Device Sequence Number: 8309811
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: (01)00888867199354(11)250804(17)300731(10)15476962
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/18/2026

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?: No
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown