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

Model Number	FASTPASS SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
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 the shoulder arthroscopy that the handle of the scorpion instrument had broken off inside the patient's body.The broken pieces were retrieved from 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 (ar-8925t).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-13997sf, fastpass scorpion, batch number 65971, was received for investigation and upon visual inspection, it was observed that the upper moving jaw has broken off (see evaluation picture 3).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to the application of excessive forces.Further the laser marks are slightly faded, and the device shows signs of metal surface oxidation (see evaluation pictures 4 - 6).

• Brand Name: FASTPASS SCORPION
• 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: 23685767
• Report Number: 1220246-2025-05293
• Device Sequence Number: 21259593
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: (01)00888867015982(10)65971
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: FASTPASS SCORPION
• Device Catalogue Number: AR-13997SF
• Device Lot Number: 65971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown