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

Model Number	FASTPASS SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/22/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13997sf fastpass scorpions clamp was cutting the wire instead of pushing it.This occurred during use, where another ar-13997sf fastpass scorpion had to be opened to finish the surgery.Additional information was provided on 02/11/2025 via (b)(4) where the arthrex subsidiary employee reported this event occurred during a rotator cuff rupture procedure when the wires were passed through the tendon.All the fragments were recovered.The suture that was breaking was an ar-13997 fibertak anchor suturetape.They used the shoulder box that was available at the hospital to complete the case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, including the instrument having been damaged prior to use.Directions for use dfu-0255-eo arthrex hand instruments c.Validation repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to the intended use.The user assumes liability and is responsible for the use of a damaged and dirty device.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: FASTPASS SCORPION
• 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: 21403917
• Report Number: 1220246-2025-00514
• Device Sequence Number: 20912268
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: (01)00888867015982(11)240423(10)15238487
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/04/2025

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
• Device Catalogue Number: AR-13997SF
• Device Lot Number: 15238487
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown