MAUDE Adverse Event Report: Arthrex, Inc. FibuLock® PRO Fracture Reduction Sleeve; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FibuLock® PRO Fracture Reduction Sleeve
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: FibuLock® PRO Fracture Reduction Sleeve
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50083341
• Report Number: 1220246-2026-04113
• Device Sequence Number: 21514858
• Product Code: LXH
• UDI-Device Identifier: 00888867529816
• UDI-Public: 00888867529816
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 09/10/2026

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: FibuLock® PRO Fracture Reduction Sleeve
• Device Catalogue Number: AR-8974-27
• Device Lot Number: 052526
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: Not provided; 09/10/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/24/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown