MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, KNEE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCORPION NEEDLE, KNEE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy the needle was defective.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 22-jul-2025 it was confirmed that when the scorpion was triggered, the needle was unable to penetrate the meniscus.As a result, the needle bent inside the device, ultimately leading to a material fracture in the lumen of the scorpion.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-12990n-1 knee scorpion needle with batch number 15163662 was received for investigation and the visual evaluation of the returned device noted that the tip of the needle was broken (see evaluation pictures 1 + 2).The fragment that broke off was returned.Functional testing was not performed due to the damage to the device.The most likely cause the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle thus, breaking the needle.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: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22742562
• Report Number: 1220246-2025-03329
• Device Sequence Number: 17993227
• Product Code: LXH
• UDI-Device Identifier: 00888867266520
• UDI-Public: (01)00888867266520(11)231106(17)281031(10)15163662
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/15/2025

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-1
• Device Lot Number: 15163662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown