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

Model Number	FASTPASS SCORPION, SL-MF
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that 7 ar-13999mf scorpions jaws are not meeting together and cannot pass the suture.This was discovered during use in a case with a slight delay in the case.All procedures were completed successfully using free needles.
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 one unpackaged ar-13999mf fastpass scorpion, sl-mf, batch 15455587, was received for investigation.Visual evaluation found that the jaw did not fully close as expected.Functional testing was not performed due to the device¿s condition.This is a known manufacturing issue, and an ncr will be opened to address it.The complaint allegation is confirmed.Refer to the investigation photographs.

• 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: 23933432
• Report Number: 1220246-2025-05908
• Device Sequence Number: 17549201
• Product Code: LXH
• UDI-Device Identifier: 00888867090590
• UDI-Public: (01)00888867090590(11)250624(10)15455587
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: FASTPASS SCORPION, SL-MF
• Device Catalogue Number: AR-13999MF
• Device Lot Number: 15455587
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown