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

Model Number	FASTPASS SCORPION, SL-MF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/03/2025, it was reported by a facility representative via (b)(4) that an ar-13999mf fastpass scorpion cut the suture as it passes.This was discovered during a knee arthroscopy procedure with no patient harm.The case was completely successfully with another device.
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 complaint allegation is confirmed.One unpackaged ar-13999mf serial/batch number (b)(6) was received for investigation.Functional testing was performed and revealed that although the reported allegation cannot be confirmed, the jaws of the device are unable to close as intended.Visual inspection noted that the device had noticeable signs of use and normal wear and tear.The most likely cause is attributed to repeated use of the device over time, resulting in wear and tear.The device was manufactured on 27-sep-2023.

• 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: 23584492
• Report Number: 1220246-2025-05103
• Device Sequence Number: 9641826
• Product Code: LXH
• UDI-Device Identifier: 00888867090590
• UDI-Public: (01)00888867090590(11)230927(10)15146863
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 15146863
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown