MAUDE Adverse Event Report: ARTHREX, INC. REELPASS SUTR LASSO,90° CRV STR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REELPASS SUTR LASSO,90° CRV STR
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2025
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
On 07/24/2025, a facility representative reported via (b)(4) that an ar-6069-90 90-degree reelpass suture lasso failed.The surgeon was performing a shoulder labral repair.Before the case, the passer was prepped by expelling a decent amount of monofilament and cutting flush.After introducing the reelpass and hooking it under the labrum, he rolled the wheels to expel the monofilament.While trying to remove the passer, it was found that the reelpass was stuck and would not expel any more suture.The surgeon tried to pull the suture from the retriever manually, but none would come out.The case was completed successfully by opening up another reelpass.The item was disposed of and was not available for return.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper preparation of the device and/or improper surgical technique.(b)(4): preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.The complaint allegation could not be confirmed as the device was not received for investigation.

• Brand Name: REELPASS SUTR LASSO,90° CRV STR
• 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: 22777670
• Report Number: 1220246-2025-03423
• Device Sequence Number: 9621312
• Product Code: LXH
• UDI-Device Identifier: 00888867115934
• UDI-Public: (01)00888867115934(11)250501(17)300430(10)15429539
• 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,Followup
• Report Date (Section B): 12/09/2025

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: REELPASS SUTR LASSO,90° CRV STR
• Device Catalogue Number: AR-6069-90
• Device Lot Number: 15429539
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown