NA 03.037.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10886982070371), received between Jan 10, 2018 and Sep 24, 2026 — classified as 9 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50885542 ↗
• MalfunctionOct 16, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE ITEM BROKE INTO PIECES INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23318404 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE TFNA AIMING ARM AND ASSOCIATED PIECES GET JAMMED AND STUCK BEFORE FULL INSERTION IS ACHIEVED; IT WAS NOTED ABNORMALLY HIGH RESISTANCE IS EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321952 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE TFNA AIMING ARM AND ASSOCIATED PIECES GET JAMMED AND STUCK BEFORE FULL INSERTION IS ACHIEVED; IT WAS NOTED ABNORMALLY HIGH RESISTANCE IS EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321908 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SURGEONS THAT THE 11MM REAMER IS DULL AND NEEDS REPLACING. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046846 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SURGEONS THAT THE 11MM REAMER IS DULL AND NEEDS REPLACING. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046831 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SURGEONS THAT THE 11MM REAMER IS DULL AND NEEDS REPLACING. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046801 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SURGEONS THAT THE 11MM REAMER IS DULL AND NEEDS REPLACING. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046723 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SURGEONS THAT THE 11MM REAMER IS DULL AND NEEDS REPLACING. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046642 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SURGEONS THAT THE 11MM REAMER IS DULL AND NEEDS REPLACING. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045699 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914649 ↗
• MalfunctionNov 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  METAL DEBRIS WAS FOUND DURING POST-OP CLEANING FROM THE LATERAL DRILL USED IN A TFNA CASE. NO ADVERSE EFFECT TO PATIENT, NO DEBRIS FOUND ON PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772554 ↗
• MalfunctionNov 4, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  METAL DEBRIS WAS FOUND ON THE NEW VERSION TFNA LATERAL CORTEX DRILL (#03.037.021) DURING POST-OPERATION CLEANING EARLY THIS YEAR BEFORE JUNE IN HOSPITAL. IT WAS UNKNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. SIMILAR EVENT IS RECORDED IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599018 ↗
• MalfunctionOct 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SURGERY WAS DONE IN EARLY (B)(6) 2024. NO OTHER CLINICAL FINDING WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537972 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF (OPEN REDUCTION INTERNAL FIXATION) WITH TFNA (TROCHANTERIC FIXATION NAIL ADVANCED). WHEN DRILLING THE LATERAL CORTICAL SCREW WITH THE DRILL BIT, IT INTERFERED WITH THE NAIL. A SIMILAR CASE HAD OCCURRED AT THE SAME HOSPITAL IN THE PAST. SINCE THE MIDDLE NAIL WAS USED ON THE PATIENT WITH A NARROW MEDULLARY CAVITY LIKE THE PREVIOUS CASE, THE NAIL MIGHT HAVE BEEN BENT AND CAUSED INTERFERENCE. THE NAIL WAS INSERTED MANUALLY. AFTER THE INTERFERENCE, LOOSENING OF THE BLACK SCREW OF THE CONNECTING SCREW WAS CHECKED. THE SURGEON ALSO CHECKED TO SEE IF THE COMPRESSION NUT HAD BEEN TURNED TOO FAR, PUTTING TOO MUCH TENSION ON THE SLEEVE. HOWEVER, THE DRILL BIT INTERFERED WITH, MAKING A GRINDING NOISE. ANOTHER DEVICE WAS USED FOR DRILLING THE LATERAL CORTICAL BONE, AND IT WAS COMPLETED WITHOUT INTERFERENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THE SIMILAR CASE THAT OCCURRED IN THE PAST WAS CAPTURED IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270897 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF DRILL BIT BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207502 ↗
• MalfunctionJun 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE NAIL AND THE DRILL BIT INTERFERED WHEN DRILLING A BURR HOLE FOR THE BLADE. THE CONNECTOR AND DEVICE WERE RETIGHTENED, THE BUTTRESS NUT WAS CHECKED FOR EXCESSIVE CRIMPING, AND DRILLING WAS DONE AGAIN, BUT INTERFERENCE STILL OCCURRED. SINCE THE OUTER CORTEX WAS ABLE TO BE SHAVED, DRILLING WITH A STEPPED REAM F (03.037.022) ALLOWED REAMING WITHOUT INTERFERENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SURGEON COMMENTED AS FOLLOWS: THE NAIL WAS FORCIBLY INSERTED WITHOUT REAMING THE MEDULLARY CAVITY ALTHOUGH THE PATIENT'S FEMORAL MEDULLARY CAVITY WAS NARROW AND BOWING WAS STRONG. THUS, THE NAIL BECAME FLEXED AND INTERFERENCE BETWEEN THE NAIL AND THE DRILL BIT OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)10MM CANNULATED TAPERED DRILL BIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563896 ↗
• MalfunctionMay 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING INSPECTION BY MDR STAFF IT WAS DETERMINED THAT THE DRILL BITS WERE DULL AND WORN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10MM CANNULATED TAPERED DRILL BIT. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367287 ↗
• MalfunctionMay 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON APRIL 25, 2024, DURING INSPECTION BY MDR STAFF IT WAS DETERMINED THAT THE DRILL BITS WERE DULL AND WORN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10MM CANNULATED TAPERED DRILL BIT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367286 ↗
• MalfunctionMay 21, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON APRIL 23, 2024, USING THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. WHILE PERFORMING INSERTION OF THE LAG SCREW INTO THE FEMORAL NECK, THE WIRE WAS PLACED INTO THE FEMORAL NECK THROUGH THE AIMING ARM. THEN, THE 10 MM CANNULATED TAPERED DRILL BIT WAS PASSED OVER THE WIRE. THE TIP OF THE DRILL BIT BROKE AS IT ENTERED THE BONE. THEN, THE 6/9MM CANNULATED STEPPED DRILL WAS USED OVER THE WIRE AND THROUGH THE AIMING ARM; THE TIP ALSO BROKE WHILE IT WAS BEING USED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. ONE FRAGMENT WAS GENERATED AND WAS NOT REMOVED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 10MM CANNULATED TAPERED DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359420 ↗
• MalfunctionFeb 6, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT HARD BONE MAY HAVE CAUSED A PRESSURE BUILD UP IN THE CHUCK WHERE THE DRILL SNAPPED, GUIDE WIRE DAMAGE ALSO DUE TO STEPPED DRILL, TO CONFIRM DAMAGE TO SLEEVE. THE DRILL WAS REMOVED WITH GUIDE WIRE, METAL FRAGMENTS LEFT IN BONE FROM THE OUTER SLEEVE. THIS REPORT IS FOR ONE (1) DRILL BIT F/LATERAL CORTEX OPENING F/QUI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18650612 ↗
• MalfunctionDec 22, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS CONFIRMED THAT FOREIGN OBJECTS WERE ADHERED TO THE SCREWDRIVER, THE DRILL BIT, AND THE REAMER WHEN THE STERILIZATION AGENT INSPECTED THE DEVICES. FOREIGN OBJECTS WERE ALSO FOUND IN THE HOLLOW INTERIOR OF THE DEVICES IN QUESTION. ALTHOUGH THE DEVICES WERE FOR THE SURGERY ON (B)(6) 2023, THE SURGERY WAS CANCELLED. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383847 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 8, 2023, THE REAMER WAS BLUNT. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE10MM CANNULATED TAPERED DRILL BIT THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237761 ↗
• MalfunctionNov 9, 2023Noise, Audible; Noise, Audible

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE LAG SCREW DRILL BIT WAS GRINDING METAL ON METAL THROUGH GUIDE SLEEVE. THERE IS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 10MM CANNULATED TAPERED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104419 ↗
• MalfunctionJul 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEVICE WAS RECEIVED BACK IN A BAG, TAGGED AS DAMAGED. BROKEN 10MM CANNULATED TAPERED DRILL BIT 300MM DRILL WAS DAMAGED AND SENT BACK TO WAREHOUSE. THERE WERE NO PATIENT CONSEQUENCES OR OUTCOME. THIS REPORT IS FOR ONE (1) DRILL BIT F/LATERAL CORTEX OPENING F/QUI THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379642 ↗