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

Model Number	FASTPASS SCORPION, SL-MF
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-13999mf fastpass scorpion bottom jaw did not align with the top jaw and the suture did not pass through the rotator cuff.This was discovered during the case.Another device was used to complete the case with no patient harm.
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.Complaint allegation is not confirmed.-upon visual inspection no issues with the device were found.-functional testing was performed, and it was noted that the jaws of the fastpass scorpion, sl-mf do not close all the way.This is a known manufacturing issue addressed in a nonconformance.

• Brand Name: FASTPASS SCORPION, SL-MF
• 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: 23960535
• Report Number: 1220246-2026-00062
• Device Sequence Number: 9448378
• Product Code: LXH
• UDI-Device Identifier: 00888867090590
• UDI-Public: (01)00888867090590(11)240209(10)15204964
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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, SL-MF
• Device Catalogue Number: AR-13999MF
• Device Lot Number: 15204964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown