Arthrex® AR-8724VCL-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867323957), received between Sep 9, 2025 and Sep 9, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  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 PA

  Patient problems: Numbness

  MAUDE report 23005596 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  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 (B)(6) 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

  Patient problems: Numbness

  MAUDE report 23005578 ↗