MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 12MM; BONE FIXATION SCREW

Model Number	LO-PRO SCRW,TI,3.5MMX 12MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a clindex notification was received indicating that a patient enrolled in the hand and wrist registry had developed carpal tunnel syndrome.The patient had previously presented for follow-up on (b)(6) 2025, reporting progressive numbness in the thumb, index, and long fingers following surgery.Ultrasound evaluation of the right carpal tunnel revealed findings consistent with carpal tunnel syndrome.To alleviate symptoms, the patient underwent right carpal tunnel release surgery on (b)(6) 2025.This event was determined to be related to the kreulock screw utilized during the distal radius fracture fixation procedure performed on (b)(6) 2025.Additional information was received on 8/20/2025: during the procedure on (b)(6) 2025, the patient was implanted with an ar-8724vcl-18 val kreulock screw, an ar-8724vcl-16 val kreulock screw, an ar-8724vcl-14 val kreulock screw, an ar-8935-12 low profile screw, and an ar-8916vnr-03 volar distal radius plate.No arthrex products were explanted or implanted during the right carpal tunnel release surgery on (b)(6) 2025.The surgeon confirmed that the patient's carpal tunnel syndrome is not related to the arthrex products, as many patients experience this issue during the postoperative period following distal radius fracture fixation.During the most recent postoperative visit, the patient reported increased sensation in the fingers, suggesting ongoing nerve recovery.
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 the most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 12MM
• Common Device Name: BONE FIXATION SCREW
• 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: 23005506
• Report Number: 1220246-2025-03781
• Device Sequence Number: 16081318
• Product Code: HRS
• UDI-Device Identifier: 00888867131934
• UDI-Public: 00888867131934
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• 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): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 12MM
• Device Catalogue Number: AR-8935-12
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown