MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION SL-MF WITH FLUSHPORT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FASTPASS SCORPION SL-MF WITH FLUSHPORT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 during a surgery that the a screw fell out of the device and disassembled it.The screw or any other parts did not fall into the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with another part number.It was not necessary to switch the surgical technique or do a second surgery.On (b)(6) 2025 (b)(6): further information received that the finger spring and one handle pin which hold the finger were fell out.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-13999mff, fastpass scorpion sl-mf, with batch 13821328 was received for investigation and the evaluation revealed that the pin that holds the trigger and the handpiece together is missing (see evaluation picture 3) and therefore the trigger is disassembled.Functional testing was not performed due to the damage to the device.This is most likely caused by wear and tear due to the age of the device (manufacturing year 2021).

• Brand Name: FASTPASS SCORPION SL-MF WITH FLUSHPORT
• 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: 22794274
• Report Number: 1220246-2025-03471
• Device Sequence Number: 8286634
• Product Code: LXH
• UDI-Device Identifier: 00888867293410
• UDI-Public: (01)00888867293410(11)210730(10)13821328
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/16/2025

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: FASTPASS SCORPION SL-MF WITH FLUSHPORT
• Device Catalogue Number: AR-13999MFF
• Device Lot Number: 13821328
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown