NA 03.010.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982067722), received between Jul 27, 2017 and Apr 30, 2026 — classified as 12 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DRILL BIT ARRIVED WITH A BROKEN TIP AND WAS NOT USABLE. THE DEVICE WAS FOUND BROKEN IN THE TRAY PRIOR TO USE, AND ANOTHER DRILL BIT FROM A DIFFERENT SET WAS USED INSTEAD. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047281 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT DURING DISTAL LOCKING THE DRILL BIT BROKE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21927948 ↗
• MalfunctionMar 22, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 AT THE START OF THE PROCEDURE, IT WAS FOUND THAT TWO (2) 3.2MM DRILLS WERE FRACTURED AND WERE MISSING THEIR TIPS. THIS MADE THE SURGERY A LITTLE MORE DIFFICULT FOR THE SURGEON AS TO PERFORM DISTAL BLOCKS, THE TIPS OF THE DRILL BITS ARE ESSENTIAL FOR BETTER PLACEMENT IN THE BONE AND DO NOT SLIP. THE SURGERY WAS DELAYED SINCE NEITHER OF THE TWO DRILLS HAD THEIR TIP FOR A GOOD PERFORATION. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18963127 ↗
• MalfunctionMar 22, 2024Break; Break

  SURGERY WAS SUCCESSFULLY COMPLETED. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 18962951 ↗
• MalfunctionJan 22, 2024Break; Failure to Cut; Break; Failure to Cut

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF FOR A HUMERUS FRACTURE. WHILE THE SURGERY WITH A MHN LONG WAS PERFORMED, A SURGEON CLAIMED THAT THE DRILL BIT WAS NOT SHARP ENOUGH. IT WAS TURNED OUT THAT THE DRILL BIT WAS CHIPPED AND FRAGMENTS OF IT REMAINED IN THE PATIENT'S BODY. THE SURGEON REMOVED THE FRAGMENTS AND CONTINUED THE PROCEDURE WITH ANOTHER DRILL BIT OF THE SAME DIAMETER. AFTER THE SURGERY, IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS REMAINED IN THE BODY BY X-RAYS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THERE WAS NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554866 ↗
• MalfunctionDec 13, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE DRILL BITS IN QUESTION FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FEW MINUTES OF SURGICAL DELAY USING ANOTHER DRILL BIT. THERE WAS NO ADVERSE PATIENT IMPACT. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317771 ↗
• MalfunctionDec 13, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE DRILL BITS IN QUESTION FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FEW MINUTES OF SURGICAL DELAY USING ANOTHER DRILL BIT. THERE WAS NO ADVERSE PATIENT IMPACT. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317762 ↗
• MalfunctionNov 16, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON 27-OCTOBER-2023, A SCREW WAS DRILLED TOWARDS THE FEMORAL NECK AND THE BIT BROKE. PART OF THE DRILL BIT WAS LEFT IN THE PATIENT, IT COULD NOT BE REMOVED. ADDITIONALLY, THE SHORT DRILL BIT WAS PASSED THROUGH FOR DISTAL BLOCKS AND BROKE AS WELL. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18148620 ↗
• MalfunctionOct 31, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION BROKE. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039572 ↗
• MalfunctionOct 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023 DURING AN UNKNOWN PROCEDURE, THE DRILL BITS IN QUESTION FRACTURED AT THEIR TIPS. THE TIPS OF THE DRILL BITS REMAIN INSIDE OF THE PATIENT¿S BONE, BECAUSE OF THEIR SMALL SIZE THEY COULD NOT BE RECOVERED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17987056 ↗
• MalfunctionOct 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE DRILL BITS IN QUESTION FRACTURED AT THEIR TIPS. THE TIPS OF THE DRILL BITS REMAIN INSIDE OF THE PATIENT¿S BONE, BECAUSE OF THEIR SMALL SIZE THEY COULD NOT BE RECOVERED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17987052 ↗
• MalfunctionSep 18, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE TIPS OF THE DRILL BITS IN QUESTION WERE FRACTURED, LEAVING THE FRACTURED TIPS INSIDE OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17765708 ↗
• MalfunctionSep 18, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2023, THE TIPS OF THE DRILL BITS IN QUESTION WERE FRACTURED, LEAVING THE FRACTURED TIPS INSIDE OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17765706 ↗
• MalfunctionMar 7, 2023Break; Break

  THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497336 ↗
• MalfunctionMar 6, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE TWO BITS IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486717 ↗
• MalfunctionMar 6, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TWO BITS IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486716 ↗
• InjuryFeb 13, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION BROKE DURING DRILLING. A FRAGMENT WAS GENERATED AND WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. NO ADVERSE IMPACT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16363697 ↗
• MalfunctionFeb 9, 2023Break; Break

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DRILL BIT IN QUESTION ARRIVED BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334481 ↗
• InjuryNov 7, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS IN QUESTION BROKE DURING AN UNKNOWN PROCEDURE. FRAGMENTS WERE GENERATED AND REMAINED INSIDE OF THE BONE OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15745626 ↗
• InjuryNov 7, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS IN QUESTION BROKE DURING AN UNKNOWN PROCEDURE. FRAGMENTS WERE GENERATED AND REMAINED INSIDE OF THE BONE OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15745614 ↗
• MalfunctionNov 1, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING A SURGERY THE SURGEON SAID THE DRILL BIT WAS DULL. A NEW DRILL BIT WAS SELECTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709748 ↗
• MalfunctionOct 3, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE DEPTH GAUGE IN QUESTION WAS FOUND TO BE TWISTED, AND THE DRILL BIT IN QUESTION BROKE, LEAVING A FRAGMENT BEHIND IN THE PATIENT. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527671 ↗
• InjurySep 29, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE HUMERUS WITH MULTILOC HUMERAL NAIL, THE DRILL BIT BROKE. A PIECE WAS RETAINED IN THE PATIENT. A NEW SCREW HOLE WAS TARGETED WITH ANOTHER DRILL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 2-MINUTE DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15501089 ↗
• InjurySep 20, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT IN QUESTION BROKE WHILE DRILLING INTO THE BONE. A FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15457735 ↗
• MalfunctionSep 19, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2022, THE DRILL BIT IN QUESTION BROKE AT THE TIP WHILE DRILLING THE DISTAL NAIL HOLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446804 ↗