NA 03.010.104Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886982067746), received between Feb 23, 2017 and Sep 23, 2026 — classified as 13 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that during the procedure, the drill bit broke due to hammer impact while performing distal locking. There was no patient harm and no surgical delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870637 ↗
• MalfunctionJun 16, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BREAKS OFF DURING THE PROCEDURE AND REMAINS EMBEDDED IN THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25522750 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT IN THE SURGERY THE SPECIALIST BROKE THE TIP OF THE 4.2 BIT BY PIERCING THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 25231030 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TWO DRILL BITS BREAK WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092641 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TWO DRILL BITS BREAK WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084462 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT THE DRILL BIT Ø4.2 CALIBR L145 3FLUTE F/QUIC BROKE AT THE TIP DURING AN INTRAOPERATIVE PROCEDURE. THE EVENT OCCURRED WHEN THE DRILL BIT WAS USED AFTER A POLE WAS PLACED TO DIRECT A NAIL; THE BROKEN FRAGMENT WAS REMOVED AND THE SCREW WAS PLACED IMMEDIATELY. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084273 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT DURING THE DISTAL BLOCKAGE OF THE NAIL, THE TIP OF THE BIT WAS FRACTURED; IT WAS SENT WITH RED TAPE. THE CONNECTING SCREW DOES NOT HOLD THE SPIRAL SHEET WELL: THE THREAD STEP FEELS HARD WHEN ATTEMPTING TO THREAD AND DOES NOT COMPLETE THE TURNS NECESSARY TO HOLD THE SHEET PROPERLY. THE IMPACTOR HANDLE OF THE BLADE IS LOOSE IN THE RUBBER, WHICH MAKES IT DIFFICULT TO HOLD ON IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790393 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THE DRILL BIT BROKE DURING THE DRILLING. THERE WERE NO COMPLICATIONS; THE SURGERY WAS SUCCESSFUL. THERE WAS ANOTHER DRILL BIT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512171 ↗
• MalfunctionMar 4, 2026Material Deformation

  IT WAS REPORTED THAT EMPHASYS TO PINNACLE CUP ADAPTOR THREADS WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507148 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THE END OF DRILL BIT HAS SNAPPED OFF INSIDE THE PATIENT'S TIBIA. RETRIEVAL OF THE END OF THE DRILL BIT WAS ATTEMPTED BUT WAS UNSUCCESSFUL. AN X-RAY WAS TAKEN AND SAVED AS EVIDENCE OF THE LOCATION OF THE DRILL BIT THAT IS NOT HARMING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149274 ↗
• MalfunctionDec 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED TWO (2) 4.2 MM CALIBRATED DRILL BIT, 145 MM LONG, BROKE AT THE TIP WHILE BEING USED TO DRILL DISTAL LOCKING DEVICES. TWO FRAGMENTS REMAINED EMBEDDED IN THE PATIENT'S BONE. A SHORT RETAINING PIN FOR A SCREWDRIVER ALSO BROKE AT THE TIP, LEAVING FRAGMENTS EMBEDDED IN THE SCREW, WHICH IS ALSO IN THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23788303 ↗
• MalfunctionDec 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED TWO (2) 4.2 MM CALIBRATED DRILL BIT, 145 MM LONG, BROKE AT THE TIP WHILE BEING USED TO DRILL DISTAL LOCKING DEVICES. TWO FRAGMENTS REMAINED EMBEDDED IN THE PATIENT'S BONE. A SHORT RETAINING PIN FOR A SCREWDRIVER ALSO BROKE AT THE TIP, LEAVING FRAGMENTS EMBEDDED IN THE SCREW, WHICH IS ALSO IN THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23788219 ↗
• MalfunctionJul 10, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE OF RETROGRADE FEMORAL RODDING WITH RETROGRADE FEMORAL NAIL ADVANCED, IT WAS REPORTED THAT, PRIOR TO INSERTION OF RETROGRADE NAIL, SURGEON USED A 4.2MM NEEDLE POINT DRILL (CATALOG NUMBER 03.010.104) AS 'BLOCKING SCREW' TECHNIQUE OR 'POLLER SCREW' AS A REDUCTION AID. DRILL PERFORMED AS INTENDED. AT END OF PROCEDURE, AFTER ALL IMPLANTS WERE IN, THE AFOREMENTIONED DRILL WAS REMOVED, AND THE DISTAL 1CM OF DRILL FRACTURED FROM THE BASED OF THE DRILL AND REMAINED IN THE PATIENTS FEMUR. THE SURGEON DECIDED TO LEAVE THE FRAGMENT OF DRILL AS THE IMPLANT CONSTRUCT WAS UNAFFECTED AND RETRIEVING THE BROKEN DRILL PIECE WAS DETERMINED TO DO MORE HARM THAN JUST LEAVING IT. THERE WAS NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22474079 ↗
• 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 22321993 ↗
• 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 22320844 ↗
• MalfunctionJun 16, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING AN ADVANCED TIBIA NAIL PROCEDURE, THE DRILL PLUNGED OFF ANGLE AND CAUGHT THE HOLE IN THE NAIL AND BROKE. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS COMPLETED BY DRILLING ANOTHER HOLE. FRAGMENTS WERE GENERATED AND THE DRILL BIT TIP WAS LEFT IN LEG,

  Patient problems: Foreign Body In Patient

  MAUDE report 22211170 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOLDS THE TIP OF THE GUIDE SO THAT IT CAN PASS INTO THE SPINAL CANAL. THE DOCTOR BEGINS TO MAKE PERFORATIONS IN THE BONE VERY HARD AND THE FLANGE THAT BREAKS IN THE MIDDLE OF THE SURGERY. THE DOCTOR MAKES A LOT OF FORCE ON THE HEAD OF THE SCREW WITH THE SCREWDRIVER AND THE TIP OF THE SCREW IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 21936118 ↗
• 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 21892308 ↗
• MalfunctionMar 6, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A RETROGRADE FEMORAL NAIL PROCEDURE, THE 4.2 MM DRILL BIT BROKE OFF IN PATIENT AND WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21535313 ↗
• MalfunctionMay 13, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS NOTED ON APRIL 1, 2024, PRE-OPERATIVELY, A 4.2MM CALIBER DRILL BIT'S TIP IS MISSING. THIS REPORT IS FOR ONE 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297686 ↗
• MalfunctionMar 25, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DRILL BUT TIP BROKE OFF DRILLING FOR DISTAL SCREWS USING PERFECT CIRCLE TECHNIQUE. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 4.2 3-FLTD DRILL BIT QC/NEEDLE PT/145 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18969521 ↗
• MalfunctionFeb 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT A LOAN TFNA SET WAS FOUND TO HAVE BONE CONTAMINANTS IN THE DRILL BITS DURING CHECKING IN BY CSSD. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) UNK - DRILL BITS: TRAUMA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741001 ↗
• MalfunctionFeb 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 WHILE PERFORMING DISTAL BLOCKAGES, WHEN MANUALLY PASSING THE DRILL BIT IN QUESTION, THE BIT BROKE. A PART OF THE DRILL BIT REMAINED IN THE PATIENT; IT COULD NOT BE REMOVED SINCE IT WAS INSIDE OF THE NAIL HOLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18630847 ↗
• MalfunctionJan 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL BIT BROKE DURING A FEMORAL RECON NAIL PROCEDURE. THE TIP OF THE BROKEN DRILL TIP WAS LEFT IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18482526 ↗
• MalfunctionNov 30, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON 08-NOVEMBER-2023, THE DRILL BIT IN QUESTION BROKE INTRA-OP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING A REPLACEMENT DRILL BIT OF THE SAME TYPE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18241935 ↗