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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
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 the device keeps breaking the needles.There was no harm for patient, operator or third party reported.This was noticed before the surgery.There was no case involvement.No further information received.Update dw 25-sep-2024: further information was received that the needle in use with the plier broke during surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-13999mff serial/batch number (b)(6) was received for evaluation.Functional testing with the suture and a needle found that the device is working as intended.No obstruction was found on the shaft as the needle was passing through.Visual inspection revealed signs of wear and tear.Device manufacturing date; 2019.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: 20358388
• Report Number: 1220246-2024-07964
• Device Sequence Number: 7171334
• Product Code: LXH
• UDI-Device Identifier: 00888867293410
• UDI-Public: 00888867293410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/20/2025

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 SL-MF WITH FLUSHPORT
• Device Catalogue Number: AR-13999MFF
• Device Lot Number: 10435618
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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