NA 310.507Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10886982186737), received between Mar 13, 2017 and Sep 15, 2026 — classified as 16 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Break” (83 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776357 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435295 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380122 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380120 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A DRILL BIT Ø1.5 W/MARKING L96/82 2FLUTE BROKE DURING A PROCEDURE. THE BREAKAGE OCCURRED WHILE DRILLING INTO BONE, AND THE ISSUE WAS IMMEDIATELY RESOLVED BY REMOVING THE BROKEN BIT AND FRAGMENT. A REPLACEMENT DRILL BIT OF THE SAME SPECIFICATIONS WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES FOR THE PATIENT, AND THE SURGICAL SCHEDULE WAS NOT ALTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220339 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THE DRILL BIT BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056074 ↗
• MalfunctionDec 16, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE DRILL BITS WERE DULL. THERE WAS INCREASED HEAT IN THE BONE DUE TO DIFFICULTY IN THE DRILL BIT PASSING THROUGH CAUSING AN INCREASE IN THE SURGICAL TIME.

  Patient problems: Bone Notching

  MAUDE report 23821033 ↗
• MalfunctionDec 16, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE DRILL BITS WERE DULL. THERE WAS INCREASED HEAT IN THE BONE DUE TO DIFFICULTY IN THE DRILL BIT PASSING THROUGH CAUSING AN INCREASE IN THE SURGICAL TIME.

  Patient problems: Bone Notching

  MAUDE report 23821015 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE THE DRILL BIT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534896 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL ULNA FRACTURE WITH DRILL BIT. WHEN THE SURGEON DRILLED, THE TIP OF THE DRILL BIT BROKE OFF. THERE WERE NO FRAGMENTS IN THE BODY. THE SURGEON OPINED THAT BECAUSE OF THE THIN DRILL BIT TIP, THE SHAKING OF THE HAND MAY HAVE CAUSED THE LOADING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849446 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING DRILLING, THE DRILL BIT BROKE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558776 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT THE 1.5 L96 DRILL BROKE DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21535295 ↗
• MalfunctionJan 22, 2025Failure to Cut; Failure to Cut

  DULL DRILL BITS AND THE DOCTOR HAS TO APPLY A LOT OF FORCE ON THE FRACTURE DRILL.

  Patient problems: Insufficient Information

  MAUDE report 21208310 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED DURING THE SURGICAL PROCEDURE A DRILL BIT BROKE. THE SURGICAL TIME WAS EXTENDED TWENTY-FIVE (25) MINUTES TO BRING NEW EQUIPMENT.

  Patient problems: Insufficient Information

  MAUDE report 21067486 ↗
• MalfunctionDec 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE ON (B)(6) 2024, THE DRILL BIT IS FRACTURED AND FRAGMENTS REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20914687 ↗
• MalfunctionNov 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT FRACTURE OSTEOSYNTHESIS FOR DISTAL ULNA FRACTURE ON DISTAL END OF ULNA WITH THE PRODUCT IN QUESTION. IN THE SURGERY, DURING ULNAR FIXATION, THE SURGEON FELT THAT THE DRILL WAS NOT SHARP ENOUGH WHEN DRILLING PROXIMALLY WHILE PERFORMING DISTAL AND PROXIMAL SCREW FIXATION. THEREFORE, WHEN HE TRIED TO REPLACE IT WITH A SPARE DRILL, HE REALIZED THAT THE LENGTH WAS DIFFERENT, AT WHICH POINT IT WAS DISCOVERED THAT THE DRILL TIP IN QUESTION HAD BROKEN OFF AND REMAINED IN THE BONE. THE BROKEN DRILL TIP WAS ABOUT TWO MILLIMETERS (2 MM) AND WAS LODGED UNDER THE PLATE. THE SURGEON USED THE FORCEPS AND OTHER INSTRUMENTS TO TRY TO REMOVE THE PIECE, BUT THE SCREW AND PLATE HAD TO BE REMOVED ENTIRELY IN ORDER TO DO SO. HE DECIDED TO END THE OPERATION AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE SURGICAL DELAY. THE SURGEON COMMENTED THAT THE DRILL TIP WAS THIN AND BROKE WITHOUT BEING NOTICED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20737676 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2024, THE 1.5 DRILL BIT PARTED. THERE WAS NO PATIENT HARM OR DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312796 ↗
• MalfunctionAug 6, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ONE DRILL BIT WAS BROKEN AND ANOTHER LACKED EDGE. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918607 ↗
• MalfunctionMay 7, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS USING A 1.5MM DRILL BIT FOR A 2.0MM PLATE, AND THE TIP OF THE DRILL BIT BROKE OFF INTO THE PATIENT. HE THEN USED A NEW 1.5MM DRILL BIT AND THE EXACT SAME SCENARIO HAPPENED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) 1.5 DRILL BIT W/DEPTH MARK MINI QC/96 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19258757 ↗
• MalfunctionMay 7, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON APR 8, 2024, THE SURGEON WAS USING A 1.5MM DRILL BIT FOR A 2.0MM PLATE, AND THE TIP OF THE DRILL BIT BROKE OFF INTO THE PATIENT. HE THEN USED A NEW 1.5MM DRILL BIT AND THE EXACT SAME SCENARIO HAPPENED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) 1.5 DRILL BIT W/DEPTH MARK MINI QC/96 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19258751 ↗
• MalfunctionFeb 19, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHILE DRILLING THROUGH THE LCP GUIDE, THE DRILL BIT BROKE. FRAGMENTS WERE GENERATED AND LEFT IN THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM DRILL BIT W/DEPTH MARK MINI QC/96 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 18731240 ↗
• MalfunctionFeb 8, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DRILL BIT IN QUESTION BROKE OFF DURING DRILLING WHEN IT WAS USED FOR INSERTING A 2.0 CORTEX SCREW. THE BROKEN PIECE OF THE DRILL BIT WAS LEFT IN THE PATIENT¿S BODY AT THE SURGEON¿S DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø1.5 W/MARKING L96/82 2FLUTE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 18669671 ↗
• MalfunctionJan 29, 2024Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY DURING WHICH THE DRILL BIT INTERFERED WITH A K-WIRE AND BROKE OFF. IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 1.5MM DRILL BIT W/DEPTH MARK MINI QC/96 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595162 ↗
• MalfunctionNov 1, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 IT WAS IDENTIFIED THAT THE DRILL BIT IS DULL. THE PRODUCT WAS USED BECAUSE THE OTHER ONE WAS MISSING. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT W/DEPTH MARK MINI QC/96 MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18051777 ↗
• MalfunctionOct 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE 1.5 DIAMETER DRILL BIT WAS BROKEN. THERE WAS NO EFFECT OR DELAY TO THE PROCEDURE. THIS REPORT INVOLVES ONE 1.5MM DRILL BIT W/DEPTH MARK MINI QC/96 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878442 ↗