Arthrex® AR-8943-42-RURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867265769), received between Sep 8, 2025 and Jun 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT DURING A ANKLE JOINT FRACTURE SURGERY TWO DEVICES AR-8943-42-RU (LOT: 917214) BROKE. THE SECOND DRILL BROKE AFTER THE SURGEON ACCIDENTALLY DRILLED INTO METAL. 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 25536260 ↗
• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT DURING A ANKLE JOINT FRACTURE SURGERY TWO DEVICES AR-8943-42-RU (LOT: 917214) BROKE. THE FIRST BREAKAGE OCCURRED DUE TO A USER ERROR, AS THE SURGEON TRIED TO LEVER SOMETHING UP WITH THE DRILL. 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 25536078 ↗
• 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 25083369 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A DISTAL TIBIA FRACTURE SURGERY, THE DRILL BIT BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED OUT OF 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 23567654 ↗
• MalfunctionSep 8, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SURGERY ONE DRILL BIT BENT DURING USE (TIP) AND THEN THE TIP BROKE SHORTLY BEFORE THE END OF THE OPERATION. NO FRAGMENT REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE, SINCE THE TIP BROKE OFF RIGHT AT THE END. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999391 ↗
• MalfunctionSep 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SURGERY THE DRILL BIT BENT DURING USE (TIP). 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 22999072 ↗