NA 03.037.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 10886982070388), received between Jan 18, 2017 and Sep 29, 2026 — classified as 83 injuries, 256 malfunctions.

The most frequently reported specific device problem is “Break” (279 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 25 most recent of 339 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50936746 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902758 ↗
• MalfunctionSep 24, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50885533 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532739 ↗
• MalfunctionJul 14, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 25815507 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THE TIP OF THE DRILL BROKE OFF DURING USE. THE PIECES WERE ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO DELAY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25506095 ↗
• MalfunctionJun 4, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE 6MM/9MM DRILL FOR THE TFNA LAG SCREW AND THE TIP BROKE INSIDE THE FEMORAL NECK. IT WAS CONFIRMED WITH X-RAY AND SURGERY CONTINUED. THE DOCTOR USED THE LAG SCREW TO SUCCESSFULLY PUSH THE PIECE SAFELY INTO THE FEMORAL HEAD. THERE WAS NO SURGICAL DELAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25392608 ↗
• MalfunctionMay 22, 2026Break; Failure to Cut

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE FLUTES ON (2) TWO REAMERS HAD BECOME CHIPPED AND DULLED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. NO PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254381 ↗
• MalfunctionMay 22, 2026Break; Failure to Cut

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE FLUTES ON (2) TWO REAMERS HAD BECOME CHIPPED AND DULLED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. NO PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254378 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHEN DRILLING INTO A PATIENT'S FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171454 ↗
• MalfunctionApr 22, 2026Break

  THE END OF THE DRILL BIT BROKE WHEN THE SURGEON DRILLED FOR THE CEPHALIC SCREW OF THE TFNA. THEY WERE ABLE TO REMOVE THE BROKEN END OF THE DRILL BIT FROM THE PATIENT WITHOUT COMPLICATION. THE SURGERY WAS PROLONGED BY 10 MINUTES BECAUSE OF THIS INCIDENT. AN INTRAOPERATIVE X-RAY WAS PERFORMED TO LOCATE THE END OF THE DRILL BIT. AFTERWARDS, THEY WERE ABLE TO REMOVE THE TIP OF THE DRILL BIT WITH AN INSTRUMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958224 ↗
• MalfunctionMar 13, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT A STEPPED DRILL BIT WAS BROKEN. THE DAMAGE WAS DISCOVERED THE DAY AFTER SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24593834 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE STEPPED REAM F/TFNA HELICAL BLADE+SCR BROKE INTO MULTIPLE PIECES INTRA-OPERATIVELY. THE FRAGMENT WAS RETRIEVED BY THE SURGEON, AND THE DRILL BIT REQUIRED REPLACEMENT. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376409 ↗
• MalfunctionFeb 11, 2026Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CONFIRM WHETHER THE BROKEN TIP OF THE 6?MM / 9?MM CANNULATED STEPPED DRILL BIT (REF.03.037.022) WAS FULLY RETRIEVED DURING THE PROCEDURE, OR IF ANY FRAGMENT REMAINED IN THE PATIENT? WAS RETRIEVED EXCPET A SMALL FRAGMENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24315103 ↗
• MalfunctionJan 26, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE TIP OF THE 6MM/9MM CANNULATED STEPPED DRILL BIT HAD BROKEN OFF DURING A SHORT TFNA SURGERY. THE BROKEN TIP COULD NOT BE RETRIEVED AND REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24184417 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE END OF THE DRILL BROKE. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058290 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A PROPHYLACTIC PROXIMAL FEMUR FRACTURE, WITH INCREDIBLY DENSE, HARD BONE AS A RESULT OF THE TUMOR. UPON REAMING THE CANAL WITH THE RIA 2 KIT, THE PLASTIC END OF THE REAMING TUB BECAME TWISTED AND WARPED DUE TO THE INTENSE PRESSURE NEEDED TO REAM. BECAUSE OF THIS, WE WERE NOT ABLE TO FULLY PASS THE REAMER PAST THE ISTHMUS. THE MONOBLOC REAMERS WERE SUCCESSFULLY USED TO COMPLETE THE CASE. ADDITIONALLY, THE STEPPED REAM F/TFNA HELICAL BLADE+SCR F/ DRILL BIT CHIPPED AT THE END DURING DRILLING OF THE DENSE BONE, BUT THIS DID NOT AFFECT THE SUCCESSFUL COMPLETION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927486 ↗
• MalfunctionDec 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WERE DAMAGED ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827828 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH TFNA LONG. AFTER DRILLING THE FEMORAL HEAD, A PIECE OF MATERIAL, WHICH APPEARED TO BE A METAL FRAGMENT RATHER THAN A BONE FRAGMENT, WAS FOUND STUCK IN THE FLUTED PART OF THE DRILLING BIT. USING AN IMAGE INTENSIFIER, THE SURGEON CONFIRMED THAT THERE WAS NO DAMAGE TO THE IMPLANTED NAIL AND NO OTHER METAL FRAGMENTS REMAINING IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643732 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH A LONG NAIL FOR FEMORAL TROCHANTERIC FRACTURES WITH A LARGE POSTERIOR FRAGMENT. AFTER INSERTING THE NAIL, THE SURGEON INSERTED A GUIDEWIRE INTO THE BONE HEAD. BECAUSE THE PATIENT WAS MALE, THE SURGEON PERFORMED REAMING OF THE BONE HEAD. AFTER REAMING, THE IMAGE INTENSIFIER WAS CHECKED, AND 4 METAL PIECES WERE VISIBLE. THE SURGEON USED A PAIR OF NUCLEUS FORCEPS AND REMOVED ALL 4 METAL PIECES IN ABOUT 15 MINUTES. THE SURGEON INSERTED A BLADE AND FINISHED FIXATION OF THE CENTRAL BONE FRAGMENT. WHEN THE EXTRACTED 4 METAL PIECES WERE EXAMINED, THEY WERE FOUND TO BE THE CUTTING EDGE OF THE REAMER. THE SURGEON COMMENTED THAT PERHAPS THE REAMER BROKE BECAUSE HE WAS TRYING TO ADVANCE IT WITH A LITTLE CONTROL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES' DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416035 ↗
• MalfunctionOct 22, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE STEPPED REAMER FOR TFNA HELICAL BLADE AND SCREW FOR QUICK COUPLING FOR DHS/DCS BROKE DURING THE SURGERY. THE SURGEON COULDN'T GET THE BREAKING PIECE. IT STILL IN THE PATIENT FEMORAL NECK. FRAGMENTS WERE GENERATED AND COULD NOT BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23357795 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286287 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285617 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285554 ↗
• MalfunctionSep 10, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE SURGEON'S OPINION ON THE RISK OF THE FRAGMENT BEING INSITU? - HE DID NOT SEEM TOO WORRIED AS FRAGMENT WAS SMALL AND NOT TOUCHING FINAL IMPLANT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23017678 ↗