NA 315.92Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982189431), received between Nov 20, 2018 and Sep 9, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692735 ↗
• MalfunctionSep 9, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692734 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279589 ↗
• MalfunctionMay 11, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR ACETABULAR FRACTURE WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, DURING DRILLING, THE DRILL BIT IN QUESTION INTERFERED WITH A SCREW IN QUESTION, CAUSING THE DRILL TIP TO BREAK OFF AND REMAIN IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. REGARDING THE RELATIONSHIP BETWEEN THIS INCIDENT AND THE PRODUCT, THE SURGEON COMMENTED THAT THE DRILL BIT BROKE BECAUSE IT INTERFERED WITH A SCREW THAT HAD ALREADY BEEN INSERTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25137600 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF DRILL BIT BROKE INTRAOPERATIVELY ON AN UNKNOWN DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885635 ↗
• MalfunctionSep 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024. A DRILL BIT BROKE OFF AND REMAINED IN THE PATIENT. THIS REPORT IS FOR A 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20207456 ↗
• InjuryJul 25, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM PERU REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING OSTEOSYNTHESIS OF THE PELVIC SEGMENT, THE SURGEON NEEDED TO ORIENT THE DRILL BIT IN QUESTION AT AN ANGLE THAT WAS PREVENTED BY THE PATIENT SOFT TISSUES. AT THE MOMENT OF ACTUATING THE MOTOR, THE BIT BROKE AND REMAINED INSIDE OF THE BONE OF THE PATIENT. IT WAS ATTEMPTED TO REMOVE THE FRAGMENT BUT WAS UNSUCCESSFUL, AFTER DOCTOR EVALUATION IT WAS DETERMINED THAT THE FRAGMENT WOULD NOT CONFLICT WITH SOFT TISSUES OR OTHER IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17391289 ↗
• MalfunctionMar 1, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2023, AS PREVIOUSLY REPORTED, THE SURGEON AGAIN HAS COMPLAINED ABOUT THE REDUCTION FORCEPS BEING DULL. THE HOSPITAL HAS PREVIOUSLY BEEN ASKED TO REPLACE THE FULL FORCEPS, HOWEVER NOT ALL OF THEM HAVE BEEN REPLACED YET. ADDITIONALLY A 2.5 DRILL BIT WENT DULL AFTER DRILLING SEVERAL HOLES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.5 3-FLTD DRILL BIT QC/230/200 CALIB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460917 ↗
• InjuryAug 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE DRILLING IN THE DISTAL HUMERUS, THE SURGEON BROKE OFF THE END OF THE 2.5 DRILL BIT. THE FRAGMENT REMAINED IN THE PATIENT. THE SURGEON ELECTED TO NOT ATTEMPT TO REMOVE THE DRILL. WHILE INSERTING A 3.5 CORTEX SCREW THROUGH THE SAME DRILL HOLE, THE NEAR PORTION OF THE SCREW BROKE. THE SCREW FRAGMENTS WERE REMOVED, AND A SHORTER SCREW WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES/OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 2.5 3-FLTD DRILL BIT QC/230/200 CALIB. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15165922 ↗
• MalfunctionJun 2, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, TWO DRILL BITS WERE DULL. PROCEDURE WAS COMPLETED WITH NO DELAY. PATIENT STATUS WAS OKAY. THIS REPORT IS FOR A 2.5MM THREE-FLUTED DRILL BIT QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575649 ↗
• InjuryJul 7, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON BROKE THE 2.5MM THREE FLUTED DRILL BIT IN THE PELVIC BONE, CHOSE NOT TO TRY AND RETRIEVE IT FROM THE BONE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 12127403 ↗
• InjuryAug 5, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ACETABULUM PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS DRILLING, THE TIP OF THE DRILL BIT BROKE OFF UNTO THE PATIENT. A FRAGMENT WAS GENERATED FROM THE BROKEN DEVICE AND THE BROKEN TIP OF THE DRILL BIT WAS LEFT INSIDE THE PATIENT. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 10366966 ↗
• InjuryJun 19, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020 WHILE PRE-DRILLING FOR A 3.5 CORTICAL SCREW THE LONG 2.5MM DRILL BIT TIP BROKE OFF. FRAGMENTS WERE GENERATED AND WERE NOT REMOVED EASILY SO THE DRILL BIT TIP WAS LEFT ALONE. . A NEW DRILL BIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. CONCOMITANT DEVICE: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury; No Code Available

  MAUDE report 10175293 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ANTERIOR PELVIC FLOOR REPAIR ON (B)(6) 2018, WHILE FIXING THE ACETABULUM, A THREE-FLUTED DRILL BIT WAS USED TO PREPARE A PATHWAY FOR A 3.5 CORTICAL SCREW. THE SURGEON ATTEMPTED TO BEND OR CHANGE DIRECTION OF DRILLING WHILE THE FLUTED END OF THE DRILL WAS IN THE BONE, THE TIP OF THE DRILL BROKE OFF IN THE PATIENT. THE UNKNOWN PLATE WAS REMOVED TO RETRIEVE THE BROKEN FRAGMENTS. FRAGMENTS WERE EASILY RETRIEVED AND THROWN INTO THE SHARPS BIN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: PLATE (PART #: UNKNOWN, LOT#: UNKNOWN, QUANTITY #: UNKNOWN), 3.5 CORTICAL SCREW: TRAUMA (PART #: UNKNOWN, LOT#: UNKNOWN, QUANTITY #: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.5MM THREE-FLUTED DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253489 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN SURGERY, WHILE DRILLING ONE (1) CALIBRATED DRILL BIT AND ONE (1) THREE-FLUTED DRILL BIT WERE BROKEN. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.5MM THREE FLUTED DRILL BIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092572 ↗