Arthrex® AR-8916VNC-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867130753), received between Jan 5, 2026 and Jan 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionJan 5, 2026Failure to Advance; Defective Device

  ON 15-DEC-2025, A FACILITY REPRESENTATIVE REPORTED VIA SEMS (B)(4) THAT (QTY. 2) (B)(6) 2.4 MM X 22 MM LOW-PROFILE LOCKING SCREWS WOULD NOT THREAD INTO THE PLATE, BUT THE THIRD ONE WORKED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. THE REP ADVISED THE EVENT OCCURRED DURING AN OPEN REDUCTION INTERNAL FIXATION OF A DISTAL RADIUS FRACTURE. A 1.7 DRILL BIT AND A CORRECT GUIDE WERE USED PRIOR TO INSERTING THE SCREW, AND THE BONE QUALITY WAS ADEQUATE. NOTHING BROKE, AND NO ADDITIONAL SCREWS OR PLATES CONTAINED A PRODUCT ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957126 ↗
• MalfunctionJan 5, 2026Failure to Advance; Defective Device

  ON 15-DEC-2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 2) AR-8916VNC-22 2.4 MM X 22 MM LOW-PROFILE LOCKING SCREWS WOULD NOT THREAD INTO THE PLATE, BUT THE THIRD ONE WORKED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. THE REP ADVISED THE EVENT OCCURRED DURING AN OPEN REDUCTION INTERNAL FIXATION OF A DISTAL RADIUS FRACTURE. A 1.7 DRILL BIT AND A CORRECT GUIDE WERE USED PRIOR TO INSERTING THE SCREW, AND THE BONE QUALITY WAS ADEQUATE. NOTHING BROKE, AND NO ADDITIONAL SCREWS OR PLATES CONTAINED A PRODUCT ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957120 ↗