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

Model Number	FASTPASS SCORPION
Medical Device Problem Codes	Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/22/2024, it was reported by a facility representative via (b)(4) that an ar-13997sf fastpass scorpion wont close as its loose.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-13997sf serial/batch number (b)(6) was received for investigation.Visual inspection noted wear on the body of the device: fading and material degradation.- functional test was performed and found that the sutures would fray when passing the needle.The most likely cause is wear and tear.The manufacturing date is 2016.

• 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: 20616622
• Report Number: 1220246-2024-08426
• Device Sequence Number: 7453116
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: (01)00888867015982(11)160503(10)74713
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 74713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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