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	10/08/2024
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 that during a bankart surgery the shuttling suture was not rolling out of the hook.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with another device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-6069-45r/ batch 15215387, was received for investigation.Upon visual inspection, no problems were found were noted with the device.Functional testing noted resistance when engaging the wheel.Additionally, the wire only advanced 1cm from the tip.The thumbwheels should be advanced slowly in a backward movement to advance the suture.The most likely cause for the reported failure can be attributed to user error due to excessive force being used when engaging the wheel.

• 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: 20504380
• Report Number: 1220246-2024-08202
• Device Sequence Number: 8258234
• Product Code: LXH
• UDI-Device Identifier: 00888867115873
• UDI-Public: (01)00888867115873(11)240304(17)290228(10)15215387
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/28/2025

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,45° CRV RT
• Device Catalogue Number: AR-6069-45R
• Device Lot Number: 15215387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2024
• 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