Arthrex® AR-8916-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867048942), received between Mar 10, 2017 and Apr 27, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY WITH A DISTAL RADIUS PLATE THE DRILL BIT BROKE. THE DEVICE DIDN´T BREAK INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002773 ↗
• MalfunctionAug 12, 2024Break; Break

  ON 16 JULY 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT BOTH AN AR-8916-14 DRILL BIT, 1.7MM AND AN AR-18700-54 DRIVER SHAFT, T8, SELF RETAINING, AO, BROKE DURING USE. THIS OCCURRED ON (B)(6) 2024 IN FLINDERS MEDICAL CENTRE DURING A NAVICULAR ORIF. USING ARTHREX EQUIPMENT FOR OPEN REDUCTION INTERNAL FIXATION 1.7MM DRILL BIT (REF: AR-8916-14) SNAPPED AT DRILL TIP. 2.4MM T8 SCREWDRIVER (REF: AR-18700-54) SNAPPED WHILE SCREWING LOCKING SCREW INTO LOCKING PLATE. AR-18724P-54 PLATE REMOVED FROM PATIENT AS SCREW THREAD SECURED INTO PLATE AND UNABLE TO BE REMOVED. ALL ARTHREX STOCK REMOVED AND DISCARDED. THE CASE WAS COMPLETED SUCCESSFULLY USING A SYNTHES VA FOOT SET. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19960673 ↗
• MalfunctionJun 17, 2024Unstable; Unstable

  IT WAS REPORTED THAT THERE WAS A LOT OF BLURRING WHEN ATTACHING TO THE DRILL. IT WAS A SITUATION WHERE THE AXIS WAS BLURRED. WHEN USED WITH A VARIABLE GUIDE, IT WAS NOT POSSIBLE TO DRILL SAFELY. THE SURGEON USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548196 ↗
• InjuryMar 10, 2017Break

  IT WAS REPORTED THAT THE 1.7MM DRILL BIT, AR-8916-14, WAS BEING USED IN A RIGHT ORIF WRIST PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE DRILL BIT BROKE OFF IN THE RADIUS, APPROXIMATELY 8.0 MM FROM THE DISTAL TIP. THE DRILL TIP WAS NOT RETRIEVED FROM THE PATIENT AS IT BROKE WITHIN THE RADIAL BONE. AN UNPLANNED INCISION WAS NECESSARY TO COMPLETE THE PROCEDURE. A RIGHT NARROW PEEK GUIDE, AND RETENTION SCREW WERE ALSO USED IN THIS PROCEDURE SUCCESSFULLY. THE PROCEDURE WAS COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6394882 ↗