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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff surgery there was a problem with the jaws of the scorpion.No part of the device broke off.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.***update 02-jan-2025 it was confirmed that the jaws were regularly jammed.
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 reported event was confirmed as one unpackaged ar-13999mff, fastpass scorpion sl-mf with flushport, batch number 15363515, was received for investigation and upon functional inspection, it was observed that the jaw does not close completely as expected due to a loose shaft (see evaluation pictures 3 + 4).No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to an internal manufacturing issue.Further the device shows signs of metal surface oxidation at the distal end (see evaluation pictures 5 + 6).

• 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: 24019121
• Report Number: 1220246-2026-00110
• Device Sequence Number: 9191063
• Product Code: LXH
• UDI-Device Identifier: 00888867293410
• UDI-Public: (01)00888867293410(11)241218(10)15363515
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 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 SL-MF WITH FLUSHPORT
• Device Catalogue Number: AR-13999MFF
• Device Lot Number: 15363515
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown