NA 4200355035Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540217165), received between Feb 18, 2019 and Sep 15, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Fracture

  It was reported that during a T2 3×4 procedure, the drill broke while being removed. It was also reported that upon visual inspection, the drill tip was found to be protruding on the opposite side, so an incision and expansion were performed on the opposite side to remove the broken section. It was further reported that the procedure was completed successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775717 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399828 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986070 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING A T2H PROCEDURE. THE DRILL TIP BROKE OFF. IT WAS ALSO REPORTED, THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED, THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962735 ↗
• MalfunctionApr 24, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801654 ↗
• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL BIT BROKE, THE BOKE FRAGMENT WAS REMOVED BY HAND. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362011 ↗
• InjuryMay 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE; THE DRILL BIT BROKE. IT WAS FURTHER REPORTED THAT THERE WAS A 30 MINUTE DELAY RESULTING IN PROLONGED ANESTHESIA TIME AND INCREASED BLOOD LOSS AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14517500 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO DRILLS BROKE DURING THE NAILING OF A PROXIMAL HUMERAL FRACTURE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13605008 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO DRILLS BROKE DURING THE NAILING OF A PROXIMAL HUMERAL FRACTURE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604902 ↗
• MalfunctionApr 10, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED DURING A SURGICAL PROCEDURE THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950052 ↗
• MalfunctionFeb 18, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE T2 DRILLING THE HUMERUS FOR DISTAL SCREW FIXATION THE DRILL BROKE AT THE BASE. IT WAS REPORTED THAT THE FRONT CORTICAL BONE DID NOT COME OFF. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8348077 ↗