MAUDE Adverse Event Report: Arthrex, Inc. LO-PRO SCRW,TI,4.5X 45MMCANN; BONE FIXATION PLATE

Model Number	LO-PRO SCRW,TI,4.5X 45MMCANN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 21-aug-2026, it was reported by a sales representative via email that an ar-8945-45ft fully threaded cannulated low profile screw fractured when the screw head separated from the shaft while being implanted.The shaft remained in the bone.All loose fragments were removed from the patient.The procedure was completed successfully.This was discovered during an amz procedure performed on (b)(6) 2026.Additional information was received on 26-aug-2026: the case was completed by implanting another screw.The replacement product used to complete the procedure was an ar-8945-50ft fully threaded cannulated low profile screw.There was no reported surgical delay; however, the surgeon redrilled and reinserted a screw.No additional anesthesia was administered to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: LO-PRO SCRW,TI,4.5X 45MMCANN
• Common Device Name: BONE FIXATION PLATE
• 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: 50670753
• Report Number: 1220246-2026-04617
• Device Sequence Number: 9513013
• Product Code: HRS
• UDI-Device Identifier: 00888867053748
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• 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): 09/08/2026

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: LO-PRO SCRW,TI,4.5X 45MMCANN
• Device Catalogue Number: AR-8945-45FT
• Device Lot Number: 15166067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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