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

Model Number	FASTPASS SCORPION, SL-MF
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11 november 2025, it was reported by a sales representative via email that an ar-13999mf, fastpass scorpion sl-mf was reported to be failing to close.This occurred on (b)(6) 2025 during a rotator cuff repair.The case was completed successfully using another scorpion.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation has been confirmed as related to a manufacturing issue, and capa-00348 has been opened to address it.

• 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: 23680062
• Report Number: 1220246-2025-05251
• Device Sequence Number: 9807927
• Product Code: LXH
• UDI-Device Identifier: 00888867090590
• UDI-Public: (01)00888867090590(11)220421(10)14952491
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/17/2026

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: 14952491
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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