MAUDE Adverse Event Report: ARTHREX, INC. 25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction

• Brand Name: 25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
• 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: 25802703
• Report Number: 1220246-2026-03754
• Device Sequence Number: 5842203
• Product Code: LXH
• UDI-Device Identifier: 00888867038905
• UDI-Public: (01)00888867038905(11)260201(17)310131(10)6008175809
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/13/2026

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: 25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
• Device Catalogue Number: AR-6068-25TR
• Device Lot Number: 6008175809
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown