NA 03.010.061Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10886982067333), received between Jan 3, 2017 and May 19, 2026 — classified as 15 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (52 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Failure to Cut

  IT WAS REPORTED THAT THE 4.2 DRILL BIT USED IN SURGERY FOR 5.0 LOCKING SCREWS HAS NO EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216911 ↗
• MalfunctionApr 8, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO PLACE A TN PROTEC NAIL RETROGRADELY (RETROFOOT STYLE), THE DISTAL LOCKING SCREWS WERE INSERTED. UPON INSERTION OF THE DRILL BIT, A SMALL PIECE BROKE OFF, REMAINING INSIDE THE PATIENT. THIS PIECE WAS IMPOSSIBLE TO REMOVE AS IT WAS EMBEDDED IN THE BONE, WITHOUT CAUSING FUNCTIONAL IMPAIRMENT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24815805 ↗
• MalfunctionJan 5, 2026Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PERFORMING THE DRILLING AND USING THE 4.2 MM DRILL BIT, IT WAS OBSERVED THAT IT WAS DULL, AND IT WAS ALSO IMPOSSIBLE TO USE THE OTHER DRILL BIT INCLUDED IN THE KIT, AS IT APPEARED BENT. SINCE NO OTHER DRILL BITS WERE AVAILABLE, THE PROCEDURE WAS COMPLETED USING THE DULL DRILL BIT, TAKING CARE NOT TO APPLY TOO MUCH PRESSURE TO AVOID BREAKING IT. DESPITE THESE DIFFICULTIES, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT AND WITHOUT ANY DELAYS IN THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957860 ↗
• MalfunctionJan 5, 2026Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PERFORMING THE DRILLING AND USING THE 4.2 MM DRILL BIT, IT WAS OBSERVED THAT IT WAS DULL, AND IT WAS ALSO IMPOSSIBLE TO USE THE OTHER DRILL BIT INCLUDED IN THE KIT, AS IT APPEARED BENT. SINCE NO OTHER DRILL BITS WERE AVAILABLE, THE PROCEDURE WAS COMPLETED USING THE DULL DRILL BIT, TAKING CARE NOT TO APPLY TOO MUCH PRESSURE TO AVOID BREAKING IT. DESPITE THESE DIFFICULTIES, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT AND WITHOUT ANY DELAYS IN THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957851 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT A DRILL BIT IS NOT DRILLING ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367783 ↗
• MalfunctionJul 29, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN PERFORMING THE PROXIMAL LOCKING, THE ARCH WAS OUT OF CALIBRATION, WHICH IS WHY THE SPECIALIST DECIDED TO LOCK BY FREEHAND AND THE BIT WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650134 ↗
• MalfunctionJul 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN OPENING THE EQUIPMENT IN THE STERILE FIELD, THE BREAKDOWN OF THE DRILL BIT WAS EVIDENT SINCE IT WAS UNWAVED. THIS NOVELTY WAS SOLVED USING A SECOND BIT OF THE SAME CHARACTERISTICS THAT ALSO COMES INSIDE THE TEAM AND WAS IN GOOD CONDITION, THUS ACHIEVING FINISH THE SURGERY. THERE WAS NO DISCOMFORT OF THE SPECIALIST, NO AFFECTATIONS TO THE PATIENT AND NO ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519024 ↗
• MalfunctionJul 16, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE SURGERY, AT THE TIME OF THE DISTAL BLOCKAGE, IT WAS EVIDENT THAT THE DRILL BIT DID NOT DRILL VERY WELL BECAUSE IT WAS WITHOUT EDGE, WHICH CAUSED DISCOMFORT TO THE SPECIALIST, SINCE HE HAD TO USE A LOT OF STRENGTH TO BE ABLE TO DRILL, INCREASING THE RISK OF HARMING THE PATIENT. EVEN SO, IT WAS POSSIBLE TO COMPLETE THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518824 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE SALES REP WAS INFORMED BY A J&J¿S DISTRIBUTOR THAT THERE WAS SOMETHING STRANGE ABOUT THE SHAPE OF THE DRILL BIT. DURING THE SURGERY ON THE (B)(6), WHEN THE PRODUCT WAS OPENED, THE SHAPE OF THE DRILL BIT WAS NOT SPECIFICALLY IDENTIFIED AND NO DISCOMFORT WAS NOTICED. HOWEVER, THE SURGEON ADJUSTED THE POSITION OF THE DISTAL LOCKING WITH A SURELOCK AND DRILLING WAS PERFORMED AFTER IT WAS DETERMINED THAT THERE WERE NO PROBLEMS. IN DOING SO, THE PORTION WAS SOMEHOW MISALIGNED, AND THE SURGEON INSERTED IT BY TRIAL AND ERROR. IT IS UNCLEAR WHETHER THIS IS RELATED TO THE SHAPE OF THE DRILL BIT. THEREFORE, AN INVESTIGATION WAS REQUESTED TO DETERMINE IF THE PRODUCT IN QUESTION WAS DEFECTIVE FROM THE BEGINNING OR IF IT IS RELATED TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387480 ↗
• 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 22321983 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320732 ↗
• MalfunctionJun 18, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE DRILL BIT WAS BEING DRILLED, IT BECAME EVIDENT THAT THE 4.2 DRILL BIT WAS DULL AND WAS NOT CUTTING PROPERLY. THIS WAS RESOLVED BY REPLACING IT WITH ANOTHER DRILL BIT WITH THE SAME CHARACTERISTICS, THUS AVOIDING DISCOMFORT FOR THE SPECIALIST AND COMPLETING THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT OR ALTERING THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284400 ↗
• MalfunctionApr 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIBIAL NAIL EX DRILL BITS ARE REPORTED TO BE DULLING. THERE WERE NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903476 ↗
• MalfunctionApr 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIBIAL NAIL EX DRILL BITS ARE REPORTED TO BE DULLING. THERE WERE NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903454 ↗
• MalfunctionApr 23, 2025Break; Break

  IT BENDS MANUAL MEDULLAR FRESE #6 AND #8 ALSO BREAK A 4.2 L145 BIT AND ANOTHER 4.2 L340 BIT. ALSO, MANGO IN T DURING THE SURGERY THE COMPANION OF CENTRAL WASHED AREA IS INFORMED.

  Patient problems: Insufficient Information

  MAUDE report 21892448 ↗
• MalfunctionMar 13, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BITS DID NOT CUT WELL. THERE WAS A LOT OF DIFFICULTY TO PIERCE THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 21594168 ↗
• MalfunctionFeb 20, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DRILL BITS DO NOT DRILL WELL.

  Patient problems: Insufficient Information

  MAUDE report 21426839 ↗
• MalfunctionFeb 20, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DRILL BITS DO NOT DRILL WELL.

  Patient problems: Insufficient Information

  MAUDE report 21426828 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE 4.2 DRILL BIT BROKE WHEN MAKING THE DISTAL BROCADE OF THE NAIL. FRAGMENTS WERE REMOVED AND ANOTHER BIT OF THE SAME CHARACTERISTICS FROM INSIDE THE EQUIPMENT WAS PASSED TO THE SPECIALIST. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DISCOMFORT OF THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349704 ↗
• MalfunctionDec 6, 2024Failure to Cut; Failure to Cut

  PATIENT UNDERWENT A FEMUR OSTEOSYNTHESIS ON (B)(6) 2024. WHEN INSERTING THE TRIPLE GUIDE IN THE DIRECTIONAL ARM, IT WAS OBSERVED THAT IT ENTERED WITH DIFFICULTY. IN ADDITION TO THE MOMENT OF DRILLING THE DISTAL BLOCK HOLE, IT WAS OBSERVED THAT THE BITS HAD NO EDGE, WHICH CAUSED DISCOMFORT IN THE SPECIALIST, BECAUSE DUE TO THE DIFFICULTY PRESENTED DURING THE PROCEDURE HE HAD TO RELEASE AND PLACE THE TRIPLE GUIDE IN MULTIPLE TIMES WHERE IN EACH OF IT THE SAME SENSATION WAS PERCEIVED (IT FELT QUITE HARD). THE BIT WAS CHANGED AND IT IS EVIDENT THAT ALTHOUGH IT MANAGES TO PASS, THIS DOES IT WITH A LITTLE DIFFICULTY; IT WAS BROCKED THEN WITH A LITTLE STRENGTH TO GET THE BITS PASSED. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860129 ↗
• MalfunctionDec 5, 2024Failure to Cut; Failure to Cut

  PATIENT UNDERWENT A FEMUR OSTEOSYNTHESIS ON (B)(6) 2024. WHEN INSERTING THE TRIPLE GUIDE IN THE DIRECTIONAL ARM, IT WAS OBSERVED THAT IT ENTERED WITH DIFFICULTY. IN ADDITION TO THE MOMENT OF DRILLING THE DISTAL BLOCK HOLE, IT WAS OBSERVED THAT THE BITS HAD NO EDGE, WHICH CAUSED DISCOMFORT IN THE SPECIALIST, BECAUSE DUE TO THE DIFFICULTY PRESENTED DURING THE PROCEDURE HE HAD TO RELEASE AND PLACE THE TRIPLE GUIDE IN MULTIPLE TIMES WHERE IN EACH OF IT THE SAME SENSATION WAS PERCEIVED (IT FELT QUITE HARD). THE BIT WAS CHANGED AND IT IS EVIDENT THAT ALTHOUGH IT MANAGES TO PASS, THIS DOES IT WITH A LITTLE DIFFICULTY; IT WAS BROCKED THEN WITH A LITTLE STRENGTH TO GET THE BITS PASSED. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856923 ↗
• MalfunctionOct 17, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20470768 ↗
• MalfunctionOct 7, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, BOTH TFNA 4.2 LONG DRILL BITS HAVE NO EDGE. THIS CAUSED NO HARM TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385801 ↗
• MalfunctionJul 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. THE SURGEON INSERTED THE NAIL IN QUESTION BY HAMMERING BUT GAVE UP HALFWAY THROUGH ITS INSERTION. THE SURGEON REMOVED THE NAIL AND DONE REAMING UNTIL 11 MM. THE DRILL BIT FOR LOCKING SCREWS INTERFERED WITH THE NAIL, BUT THE SURGEON CONTINUED THE SURGERY. AFTER INSERTION OF THE END CAP, THE LOCKING SCREW WAS FOUND TO BE INSERTED OUT OF THE HOLE TOWARD THE ANTERIOR FEMUR. THE SURGEON REMOVED THE LOCKING SCREW AND END CAP, REATTACHED THE INSERTION HANDLE, DRILLED AT THE DYNAMIC HOLE, AND SUCCEEDED IN INSERTING THE LOCKING SCREW WITHOUT INTERFERENCE. THE ASSISTANT SURGEON PRESUMED THAT THE HAMMERING DURING NAIL INSERTION LOOSENED THE SCREWS ON THE AIMING ARM, WHICH MAY HAVE CAUSED THE LOCKING SCREW TO BE INSERTED OUT OF THE HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT INVOLVES ONE (1) 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765888 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A FEMORAL TRANSVERSE FRACTURE ON (B)(6) 2024. BY MEANS OF FNA, DRILLING WAS PERFORMED TO INSERT A LOCKING SCREW, BUT THE DRILL BIT BROKE OFF IN THE MIDDLE OF THE SURGICAL PROCESS. THEREFORE, INSERTION OF THE LOCKING SCREW WAS NOT PERFORMED. THE SURGERY WAS COMPLETED WITH NO DELAY AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. MEDICAL STAFF COMMENTED THAT THE PATIENT¿S BONE WAS EXTREMELY HARD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353356 ↗