NA 324.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982191243), received between Feb 21, 2017 and Apr 3, 2026 — classified as 8 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Break; Crack

  IT WAS REPORTED THAT THE DRILL BIT WAS DAMAGED IN SURGERY. IT WAS CRACKED; BROKEN INTO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781311 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE TWO DRILL BITS BROKE OFF DURING THE SURGERY. THE SURGEON SAID IT WAS POSSIBLE THAT THE PLATE HAD INTERFERED WITH THE DRILL BITS DURING DRILLING AND CAUSED THEM TO BREAK. THE TIP OF ONE DRILL BIT REMAINED INSIDE THE PATIENT¿S BODY, BUT SINCE IT WAS INSIDE THE BONE, THE SURGEON SEEMED TO REGARD THAT NON-PROBLEMATIC. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23981290 ↗
• MalfunctionJan 6, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE TWO DRILL BITS BROKE OFF DURING THE SURGERY. THE SURGEON SAID IT WAS POSSIBLE THAT THE PLATE HAD INTERFERED WITH THE DRILL BITS DURING DRILLING AND CAUSED THEM TO BREAK. THE TIP OF ONE DRILL BIT REMAINED INSIDE THE PATIENT¿S BODY, BUT SINCE IT WAS INSIDE THE BONE, THE SURGEON SEEMED TO REGARD THAT NON-PROBLEMATIC. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23981258 ↗
• MalfunctionDec 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY FOR PELVIC FRACTURES WITH LPP. DURING SURGERY, THE SURGEON USED THE TWO DRILL BITS, BUT NEITHER WERE SHARP ENOUGH AND COULD NOT BE USED. ANOTHER DRILL BIT WAS USED FOR THE REST OF THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831473 ↗
• MalfunctionDec 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY FOR PELVIC FRACTURES WITH LPP. DURING SURGERY, THE SURGEON USED THE TWO DRILL BITS, BUT NEITHER WERE SHARP ENOUGH NOR COULD NOT BE USED. ANOTHER DRILL BIT WAS USED FOR THE REST OF THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831464 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT THE THE BIT WAS BROKEN. PIECES ARE LEFT ON THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369410 ↗
• MalfunctionSep 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE LOW-PROFILE PELVIC SYSTEM FOR AN ACETABULUM FRACTURE. THE TIP OF THE DRILL BIT BROKE OFF WHEN THE SURGEON DONE PLATE FIXATION, AND THE BROKEN PART (APPROXIMATELY 2 CM) REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS STABLE. THE SURGEON COMMENTED AS FOLLOWS: THE BREAKAGE OCCURRED BECAUSE DRILLING WAS CONTINUED WHILE THE LONG DRILL BIT WAS BENT AND APPLIED STRESS. THIS EVENT WAS A TECHNICAL ERROR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23076597 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR PELVIC FRACTURES WITH THE DRILL BIT IN QUESTION. DURING THE SURGERY, THE DRILL BIT BROKE. THE BROKEN DRILL BIT WAS RECEIVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979501 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT A 2.5 DRILL BIT OF THE PELVIS SYSTEM WAS FRACTURED, LEAVING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952465 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH DRILL BIT. DURING SURGERY, IT WAS CONFIRMED THAT THE TIP OF THE DRILL BIT HAD BROKEN OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720528 ↗
• MalfunctionApr 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. WHEN THE DOCTOR PERFORMED THE DRILLING, THE DRILL BITS WERE DULL. THE SALES REPRESENTATIVE HANDED THE SURGEON THE FOUR DRILL BITS THAT CAME WITH THE BACKUP EQUIPMENT, AND NONE OF THEM CUT WELL AND WERE DULL. NO SOLUTION WAS OFFERED, AND THE PROCEDURE WAS CARRIED OUT WITH THESE SAME DRILL BITS. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY HARM TO THE PATIENT OR ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892000 ↗
• MalfunctionApr 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON MARCH 21, 2025. WHEN THE DOCTOR PERFORMED THE DRILLING, THE DRILL BITS WERE DULL. THE SALES REPRESENTATIVE HANDED THE SURGEON THE FOUR DRILL BITS THAT CAME WITH THE BACKUP EQUIPMENT, AND NONE OF THEM CUT WELL AND WERE DULL. NO SOLUTION WAS OFFERED, AND THE PROCEDURE WAS CARRIED OUT WITH THESE SAME DRILL BITS. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY HARM TO THE PATIENT OR ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891995 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING THE PROCEDURE BECAUSE THE DOCTOR NEEDED A LONG BIT FOR THE ACCESS ROUTE BUT EVEN AT THAT SIZE, THEY WERE TOO SHORT. AT SUCH A POINT OF DISCOMFORT THEY BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21719032 ↗
• MalfunctionFeb 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY ON PELVIS WITH THE DRILL BIT. IN THE SURGERY, THE DRILL TIP BROKE OFF AND REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THE SURGEON COMMENTED THAT THE RELATIONSHIP BETWEEN THIS EVENT AND THE PRODUCT MAY HAVE BEEN DUE TO THE HARDNESS OF THE BONE AND THE USE OF A LONG DRILL TIP, WHICH MAY HAVE RESULTED IN A BREAKAGE DUE TO THE LOAD PLACED ON THE SUPPRESSED AREA. PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21303928 ↗
• MalfunctionJan 31, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE PELVIS WITH THE PRODUCT IN QUESTION. IN THE SURGERY, DURING DRILLING, THE 2.5MM DRILL TIP BROKE OFF AND REMAINED IN THE BONE. THE SURGERY WAS TERMINATED WITH THE BROKEN DRILL TIP REMAINING IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THE DOCTOR'S OPINION WAS THAT SINCE THE PATIENT WAS IN HIS OR HER 20S, THE BONE WAS HARD AND THE DRILL MAY HAVE WORN OUT AND BROKEN AS A RESULT OF THE INSERTION OF NUMEROUS SCREWS.

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

  MAUDE report 21283798 ↗
• MalfunctionJan 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR IS DISSATISFIED WITH THE SCREWDRIVER AND THE HOLDING SLEEVE, SINCE THE SHEATH DOES NOT SLIDE COMPLETELY THROUGH THE SCREWDRIVER, WHICH MAKES INSERTION OF THE SCREW DIFFICULT AND OBSTRUCTS THE SURGICAL FIELD, WHICH IS REDUCED IN THE PELVIS. THE SURGERY ENDS SUCCESSFULLY. THE 2.5 DRILL BITS ARE VERY WORN. THE SPECIALIST WAS UPSET AND DECIDED TO BEND 2 DRILL BITS AND REQUESTED THAT NEW DRILL BITS BE SENT.

  Patient problems: Insufficient Information

  MAUDE report 21252900 ↗
• MalfunctionJan 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR IS DISSATISFIED WITH THE SCREWDRIVER AND THE HOLDING SLEEVE, SINCE THE SHEATH DOES NOT SLIDE COMPLETELY THROUGH THE SCREWDRIVER, WHICH MAKES INSERTION OF THE SCREW DIFFICULT AND OBSTRUCTS THE SURGICAL FIELD, WHICH IS REDUCED IN THE PELVIS. THE SURGERY ENDS SUCCESSFULLY. THE 2.5 DRILL BITS ARE VERY WORN. THE SPECIALIST WAS UPSET AND DECIDED TO BEND 2 DRILL BITS AND REQUESTED THAT NEW DRILL BITS BE SENT.

  Patient problems: Insufficient Information

  MAUDE report 21252877 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT IN QUESTION. THE DRILL BIT WAS BROKEN OFF DURING SURGERY. THE SURGEON GUESSED THAT THE DRILL BIT WAS BROKEN OFF DUE TO TENSION WITH THE SLEEVE DURING DRILLING OR FROM CONTACT WITH THE BLADE. THE BROKEN DRILL BIT WAS REMOVED, AND THE SURGEON CONFIRMED THAT BY THE X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290574 ↗
• MalfunctionSep 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE DRILL BIT IN QUESTION FOR THE PELVIS FRACTURE. DURING DRILLING, THE DRILL BIT BROKE OFF. THE BROKEN DRILL BIT REMAINED IN THE PATIENT. THE SURGEON DETERMINED THAT IT WOULD BE DIFFICULT TO REMOVE IT AND LEFT IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20242736 ↗
• MalfunctionSep 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE TWO PIECES OF THE DRILL BIT TIP WERE BROKEN OFF IN THE PATIENT. THE FRAGMENTS WERE UNABLE TO BE RETRIEVED. X-RAYS WERE TAKEN AND MANAGEMENT WAS INFORMED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20134424 ↗
• MalfunctionJul 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING DRILLING, THE DRILL BIT BROKE OFF. IT APPEARS THAT THE DRILL BIT BROKE OFF WHEN IT WAS CHANGED DIRECTION WITH THE DRILL BIT IN THE BONE. THE SURGEON JUDGED THAT REMOVING THE BROKEN DRILL BIT FROM THE BONE WAS DIFFICULT AND USED ANOTHER DRILL BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 19764512 ↗
• MalfunctionJul 11, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, TWO DRILL BITS WERE BROKEN. FRAGMENTS WERE UNRETRIEVABLE AND LEFT IN THE PATIENT. THIS REPORT IS FOR A 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19725012 ↗
• MalfunctionJul 11, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, TWO DRILL BITS WERE BROKEN. FRAGMENTS WERE UNRETRIEVABLE AND LEFT IN THE PATIENT. THIS REPORT IS FOR A 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19724819 ↗
• MalfunctionJul 11, 2024Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE 5 BITS DO NOT CLICK INTO PLACE ON THE MOTOR'S QUICK-LOCK CHUCK. THIS REPORT INVOLVES ONE (1) 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19719470 ↗
• MalfunctionJul 11, 2024Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS FURTHER REPORTED BY THE SALES REPRESENTATIVE THAT THE USER HAD STUCK A CHIP ON EACH DRILL BIT WHICH PREVENTED IT FROM CLICKING INTO PLACE, SO THERE WAS NO PROBLEM WITH THE DRILL BITS.

  Patient problems: Insufficient Information

  MAUDE report 19719413 ↗