MAUDE Adverse Event Report: ARTHREX, INC. REELPASS SUTR LASSO,45° CRV LFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REELPASS SUTR LASSO,45° CRV LFT
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a bankart repair of the left shoulder a quantity two ar-6069-45l (lot: 12221645) malfunctioned.When the product was opened, the scrub tech attempted to run the suture by rolling the wheel to make sure it worked before handing it to the surgeon.The monofilament from the device came out about two inches and then stopped despite continuing to roll the wheels together and independently.The scrub tech then took a hemostat and tried to pull the suture out the tip as well as roll the wheel to get the suture to run but it still did not feed.A second device was opened to replace the first one but the exact same thing happened as the first.The procedure was completed successfully by using another manufacturer's device.See source data attached.
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.Complaint not confirmed.Visual inspection identified that the suture had been partially deployed.During functional testing, the suture was able to be deployed once more.No problem was observed.The reelpass was disassembled to check for proper wheel alignment, and no abnormality was noted.

• Brand Name: REELPASS SUTR LASSO,45° CRV LFT
• 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: 19136021
• Report Number: 1220246-2024-02132
• Device Sequence Number: 14623429
• Product Code: LXH
• UDI-Device Identifier: 00888867115866
• UDI-Public: 00888867115866
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: REELPASS SUTR LASSO,45° CRV LFT
• Device Catalogue Number: AR-6069-45L
• Device Lot Number: 12221645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown