NA 03.045.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982292650), received between Sep 17, 2021 and Jun 8, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIA NAIL CASE, THERE WAS A TARGETING ISSUE WITH THE SUPRAPATELLAR TIBIA NAIL. THE ENTRY POINT WAS EXCELLENT, BUT IT WAS NOTICED THAT THE DRILL BIT WAS EXTREMELY WOBBLY ON THE QUICK CONNECT NON-SYNTHES DRILL. NO OTHER DRILL BITS HAD AN OBSERVED WOBBLY SPIN. IT WAS THEN BROUGHT TO THE SALES REPRESENTATIVE'S ATTENTION THAT THE LAST FIVE DRILL BITS WERE TERRIBLY WOBBLY ON POWER AS WELL; THIS HAD BEEN OBSERVED OVER THE COURSE OF THE PAST TWO WEEKS. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS A FIVE-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436148 ↗
• MalfunctionMay 15, 2026Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 4.2MM DRILL BIT WAS WOBBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25193667 ↗
• MalfunctionMay 15, 2026Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY HAD 2 NEW DRILL BITS THAT ARE WOBBLING OFF CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187093 ↗
• MalfunctionMay 15, 2026Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY HAD 2 NEW DRILL BITS THAT ARE WOBBLING OFF CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187049 ↗
• MalfunctionMay 12, 2026Failure to Cut

  IT WAS REPORTED ON AN UNKNOWN DATE THAT 2 X DRILL BITS WERE WOBBLING OFF CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149066 ↗
• MalfunctionMay 12, 2026Failure to Cut

  IT WAS REPORTED ON AN UNKNOWN DATE THAT 2 X DRILL BITS WERE WOBBLING OFF CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149044 ↗
• MalfunctionJan 22, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ADVANCED TIBIAL NAIL PROCEDURE, THE PROXIMAL DRILL GUIDE JIG FAILED THE ALIGNMENT FOR THE PROXIMAL SCREWS. THE TABLE ALIGNMENT TEST WAS SUCCESSFULLY DONE PRIOR TO INSERTING THE NAIL IN THE PATIENT. THE ISSUE CAUSED A SLIGHT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144682 ↗
• MalfunctionJan 22, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ADVANCED TIBIAL NAIL PROCEDURE, THE PROXIMAL DRILL GUIDE JIG FAILED THE ALIGNMENT FOR THE PROXIMAL SCREWS. THE TABLE ALIGNMENT TEST WAS SUCCESSFULLY DONE PRIOR TO INSERTING THE NAIL IN THE PATIENT. THE ISSUE CAUSED A SLIGHT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144469 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN DURING THE PROCEDURE, AT THE TIME THE DOCTOR USED IT. THE ROD WAS BENT DURING THE PROCEDURE, IT WAS ALSO USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714857 ↗
• MalfunctionMay 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, WHILE DOING A TIBIA NAIL, THE AIMING ARM GOT STUCK ON THE INSERTION HANDLE. THE SURGEON WANTED TO REMOVE THE AIMING ARM TO INSERT THE NAIL FURTHER BECAUSE THE 4.2 DRILL BIT WAS MISSING THE NAIL WHILE DRILLING THE PROXIMAL STATIC AND DYNAMIC HOLE. HE WAS UNABLE TO REMOVE THE AIMING ARM FROM THE INSERTION HANDLE AFTER TRYING MANY TIMES. SURGEON TAPPED ON THE DRIVING CAP TO INSERT THE NAIL FURTHER. THE AIMING ARM WHERE IT ATTACHES TO THE INSERTION HANDLE BROKE AND TWO CARBON FIBER PIECES FELL OFF THE FIELD. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086854 ↗
• MalfunctionSep 3, 2024Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024 THERE WAS A BROKEN TIP/DULL. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4) PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130645 ↗
• MalfunctionSep 3, 2024Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024 THERE WAS A BROKEN TIP/DULL. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130635 ↗
• MalfunctionMar 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506502 ↗
• MalfunctionFeb 17, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN SURGERY SURGEON WAS DRILLING AND A PORTION OF THE DRILL BIT BROKE IN PATIENT. THE FRAGMENT WAS RETRIEVED AND SURGERY COMPLETED WITH A SURGICAL DELAY OF 5 MINUTES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398043 ↗
• MalfunctionMar 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, WHEN INSERTING THE PROXIMAL STATIC SCREW, THE DRILL BIT WAS GETTING CAUGHT ON THE NAIL POSTERIOR TO THE HOLE. THE SCREW WAS FINALLY INSERTED BEHIND THE NAIL. THE PROXIMAL DYNAMIC SCREW WAS INSERTED PROPERLY WITH NO ISSUES USING THE LONG SELF-RETAINING POWER SHAFTS FROM THE ANS LOCKING SET. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) DRILL BIT/ CALIBRATED/ Ø4.2MM EXTRA-LONG THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862240 ↗
• MalfunctionMar 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, WHEN INSERTING THE PROXIMAL STATIC SCREW, THE DRILL BIT WAS GETTING CAUGHT ON THE NAIL POSTERIOR TO THE HOLE. THE SCREW WAS FINALLY INSERTED BEHIND THE NAIL. THE PROXIMAL DYNAMIC SCREW WAS INSERTED PROPERLY WITH NO ISSUES USING THE LONG SELF-RETAINING POWER SHAFTS FROM THE ANS LOCKING SET. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862191 ↗
• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING AN UNKNOWN PROCEDURE THE TIP OF THE DRILL BIT BROKE OFF. THE OUTCOME OF THE CASE WAS NOT IMPACTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) DRILL BIT/ CALIBRATED/ 4.2MM EXTRA-LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604479 ↗
• MalfunctionSep 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHEN THE UNKNOWN TIBIAL NAIL WAS INSERTED AND THE AIMING ARM WAS CONNECTED AFTER, THE UNKNOWN TRIPLE SLEEVE AND UNKNOWN DRILL BIT WERE INSERTED BUT MISSED THE HOLE IN THE NAIL. THE BLACK TABS ON THE AIMING ARM WERE USED TO TIGHTEN DOWN THE AIMING ARM WHEN A LOUD CLICK HAPPENED. IT WAS ASSUMED IT WAS IN THE CORRECT POSITION BUT AFTER THE DRILL BIT STILL MISSED THE HOLE, IT WAS DISCOVERED THAT THE AIMING ARM WAS CRACKED ON ONE OF THE BLACK TABS. A NEW AIMING ARM REPLACED THE BROKEN ONE. THERE WAS A TEN MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) DRILL BIT/ CALIBRATED/ Ø4.2MM EXTRA-LONG. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489139 ↗