NA 4200355042Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04546540348593), received between Mar 26, 2018 and Apr 22, 2026 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Fracture” (29 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24954290 ↗
• MalfunctionJan 23, 2026Fracture

  NO CHANGE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163432 ↗
• 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 23399810 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22647323 ↗
• MalfunctionMay 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED, THAT THERE WAS NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22078579 ↗
• MalfunctionApr 21, 2025Fracture; 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 21876047 ↗
• MalfunctionJan 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY RECEIVED IN SUCH A MANNER TO INDICATE THAT ITS STERILITY HAD BEEN COMPROMISED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200734 ↗
• 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 17985865 ↗
• MalfunctionAug 7, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT THE PACKAGING WAS OBSERVED TO BE UNSEALED PRIOR TO OPENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468851 ↗
• MalfunctionJul 26, 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: Device Embedded In Tissue or Plaque

  MAUDE report 17398737 ↗
• MalfunctionJan 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION WITH INTERNAL FIXATION OF NON-UNION INTERTROCHANTERIC FRACTURE SURGERY; THE TIP OF THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION, WITH NO CLINICALLY-SIGNIFICANT SURGICAL DELAY AS A RESULT OF THIS EVENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16231753 ↗
• MalfunctionJan 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A INTRAMEDULLARY NAIL SURGERY FOR FEMORAL DIAPHYSEAL FRACTURE; WHILE DRILLING TO INSERT THE SCREW INTO THE AP HOLE, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 16150021 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE WELD WAS FRACTURED ON THE HOUSING DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15938747 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL BROKE. 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 15938743 ↗
• MalfunctionAug 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE RADIOLUCENT DRILL BIT BROKE, THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 15152837 ↗
• MalfunctionJul 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN AP HOLE OF THE T2ALPHA TIBIA SURGERY, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT¿S BONE. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021594 ↗
• InjuryJul 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE FRACTURED TIP OF THE DRILL BIT WAS STILL STUCK IN THE BONE. IT WAS FURTHER REPORTED THAT THE BONE WAS SHAVED AROUND THE DRILL TIP SO THE FRAGMENT COULD BE REMOVED SUCCESSFULLY. IT WAS ALSO REPORTED 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 14938705 ↗
• MalfunctionJun 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING T2 SCNL SURGERY, IT WAS NOTED THAT THE DRILL BIT TIP BROKE WHILE DRILLING INTO THE PROXIMAL TRUE CIRCLE HOLE AND WAS REMOVED AS PART OF THE PROCEDURE. IT WAS ALSO REPORTED 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 14748256 ↗
• MalfunctionJun 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A T2SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593989 ↗
• MalfunctionMar 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A T2SCN LONG NAIL SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13902074 ↗
• MalfunctionJan 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE DRILL BIT BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155874 ↗
• MalfunctionSep 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A T2 SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548556 ↗
• MalfunctionAug 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL BIT BROKE. IT WAS ALSO REPORTED 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 12380270 ↗
• MalfunctionDec 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ATTACHMENT STOPPED AND THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 11032141 ↗
• MalfunctionAug 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A FRACTURE REPAIR OF DISTAL FEMUR WITH NAIL, TWO RADIOLUCENT DRILL BITS BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THE DRILL FRAGMENT IS COMPLETELY BURIED IN THE BONE AND CANNOT BE REMOVED. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.THIS REPORT IS FOR THE SECOND DRILL BIT THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10471997 ↗