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

Model Number	REELPASS SUTR LASSO,45° CRV RT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 1/29/2024, it was reported by a sales representative via (b)(4) that an ar-6069-45r reelpass suture lasso malfunctioned.When the surgeon advanced the wheels to deploy the microfilament, only some would come out and then it would stop.This was discovered during a rotator cuff case.The case was completed with another ar-6069-45r with no patient harm.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in d8/9, h3, h6: component code, type of investigation, investigation findings, investigation conclusions, and h10.Investigation summary: complaint is not confirmed.Visual inspection identified no issues on the device returned.Functional testing noted that the filament went forward without any issues with the reelpass suturelasso¿, 45° curve right with shuttling suture.No problem found.

• Brand Name: REELPASS SUTR LASSO,45° CRV RT
• 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: 18713348
• Report Number: 1220246-2024-00990
• Device Sequence Number: 15217799
• Product Code: LXH
• UDI-Device Identifier: 00888867115873
• UDI-Public: 00888867115873
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 RT
• Device Catalogue Number: AR-6069-45R
• Device Lot Number: 15161162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown