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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 that during an arthroscopic cuff repair surgery the jaws of the device would not close properly and would not capture the suture properly.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation of the received ar-13999mff with batch 15176626 found that the jaw does not close completely.Functional testing with a needle (ar-13995n, batch 13941157) found no construction on the shaft.However, it was confirmed that the jaw did not close completely when the finger was pressed (see evaluation pictures 2 - 4).The most likely cause of the reported failure is wear and tear over repetitive usage.Further, the visual evaluation revealed that the handle and the tip have discoloration (see evaluation pictures 5 - 7).

• 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: 23475612
• Report Number: 1220246-2025-05003
• Device Sequence Number: 16074261
• Product Code: LXH
• UDI-Device Identifier: 00888867293410
• UDI-Public: (01)00888867293410(11)231206(10)15176626
• 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): 02/04/2026

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 WITH FLUSHPORT
• Device Catalogue Number: AR-13999MFF
• Device Lot Number: 15176626
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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