Arthrex® AR-8943-16-RURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867265752), received between Aug 10, 2021 and May 5, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A REPAIR OF A FRACTURE OF THE FOOT¿ANKLE COMPLEX THE DRILL BIT BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082881 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY USING THE FOOT AND ANKLE INSTRUMENT SET THE DRILL BIT BROKE. THE DEVICE DID NOT 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 25036182 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING A FOLLOW-UP ON A FIBULA FRACTURE THE CUSTOMER REPORTED THAT WHEN THE SURGEON DRILLED THROUGH THE GUIDE IT APPEARED THAT THE DRILL IS NOT POWERFUL ENOUGH AND SUDDENLY THE DRILL BROKE OFF. 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 24756334 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FRACTURE SURGERY THE DRILL BIT BROKE WHILST DRILLING. ALL FRAGMENTS WERE RETRIEVED FROM 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 21253863 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A PILON FRACTURE, ANTEROLATERAL ACCESS SURGERY WHILE DRILLING THE FIRST HOLE FOR THE SCREW THROUGH THE LOCKING DRILL GUIDE THE DRILL DID BREAK. THE SURGEON SUGGEST THAT HE DRILLS AGAINST THE REPOSITION K-WIRE AND THAT WHY THE DRILL BROKE. HE LEFT THE BROKEN OFF PIECE OF THE DRILL INSIDE THE BONE UNDER THE CORTICAL OF THE BONE. FOR THE FIXATION OF SCREWS HE USED ANOTHER HOLES IN THE PLATE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DRILL FROM THE INSTRUMENT SET. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21168348 ↗
• MalfunctionAug 10, 2021Break

  IT WAS REPORTED THAT DURING FOOT SURGERY THE DRILL BIT DIE BREAK OFF WHILE DRILLING. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12300536 ↗