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

Model Number	FASTPASS SCORPION-MF WITH FLUSHPORT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that the surgeon is not able to bring the thread through the tissue.The reported event was confirmed as a functional test with a needle revealed that the cannulation is blocked, it is not possible to fire the needle smoothly and this might have made it difficult to pick up the thread.The most likely cause for the reported failure is a user error.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.
Event or Problem Description
It was reported that the surgeon is not able to bring the thread through the tissue.There was no harm for patient, operator or third party reported.No further information received.16-may-2023 update.Further information were provided that the reported event occurred during a shoulder surgery.The surgery was finished successfully with a new device with the same part number.

• Brand Name: FASTPASS SCORPION-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: 19398857
• Report Number: 1220246-2024-03960
• Device Sequence Number: 20783612
• Product Code: LXH
• UDI-Device Identifier: 00888867293496
• UDI-Public: 00888867293496
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2024

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-MF WITH FLUSHPORT
• Device Catalogue Number: AR-13997MFF
• Device Lot Number: 10247362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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