NA 03.113.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982072900), received between Mar 16, 2017 and May 7, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE FRONT END OF THE DRILL BIT HAD BROKEN INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY. THE OUTCOME OF THE PATIENT IS CURRENTLY STABLE. THE DOCTORS HAVE STATED THAT THEY WILL CONTINUE TO MONITOR THE SITUATION AND WILL CONSIDER REMOVAL IF NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21978806 ↗
• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRILL BIT FRACTURED WHILE PULLING IT OUT OF THE PATIENT'S BONE. IT GENERATES AN INCREASE IN SURGICAL TIME WHEN TRYING TO REMOVE IT BUT IT WAS UNKNOWN HOW MUCH TIME WAS DELAYED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE DRILL BIT Ø2.8 W/STOP CALIBR L250/225 F/. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19104860 ↗
• MalfunctionMar 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 11-MARCH-2024 DURING A PROCEDURE, THE DRILL BIT IN QUESTION GOT COLD WELDED INTO THE PERCUTANEOUS GUIDE IN QUESTION. THERE WAS NO ADVERSE PATIENT IMPACT, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE DRILL SLEEVE WAS TAKEN OFF AND A NEW ONE WAS PUT ON, AND THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979705 ↗
• MalfunctionFeb 2, 2024Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024 USING THE MIPO FRAME, THE DRILL BIT IN QUESTION FRACTURED. THE GENERATED FRAGMENT WAS REMOVED AFTER AN UNKNOWN SURGICAL DELAY WITH NO ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DRILL BIT OF THE SAME TYPE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631010 ↗
• MalfunctionAug 28, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17635312 ↗
• MalfunctionMay 2, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BITS WERE BLUNT. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND NO PATIENT CONSEQUENCE WAS REPORTED. NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852853 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2022 DURING SURGERY THE DRILL BIT BROKE AND SPLIT AND THE SCREWDRIVER STUDS WERE BENT. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.8 W/STOP CALIBR L250/225. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054061 ↗
• MalfunctionJun 18, 2021Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  IT WAS REPORTED ON AN UNKNOWN PROCEDURE THAT LOCKING SCREW DID NOT ENGAGE WITH ONE OF THE COMBO HOLES IN THE PLATE. A NON-LOCKING SCREW WAS USED IN ITS PLACE. THE LOCKING SCREW WAS FOUND NOT BE THE PROBLEM AS THE SAME SCREW ENGAGED A DIFFERENT LOCKING HOLE. TWO NEW DRILL BITS WERE ALSO FOUND TO BE DULL AND HEATED UP THE BONE EXCESSIVELY WHEN TRYING TO DRILL WITH THEM. NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 3 DEVICE. THIS REPORT IS FOR ONE (1) 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029014 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL BITS BROKE, TERMITES FORCEPS BENT, AND SCREWDRIVER SHAFT HAD STRIPPED HEAD. THE SURGERY WAS DELAYED FOR 5 MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) CANN SD SCREWDRIVER SFT FOR 3.0 HCS T8. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591074 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2021 DURING AN UNKNOWN PROCEDURE THE DRILL BITS BROKE, TERMITES FORCEPS BENT, AND SCREWDRIVER SHAFT HAD STRIPPED HEAD. THE SURGERY WAS DELAYED FOR 5 MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS REPORT IS 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591071 ↗
• InjuryMar 31, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020, WHILE DRILLING, THE TWO (2) DRILL BITS SPLIT, LEAVING TWO FRAGMENTS INSIDE THE PATIENT. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO SURGICAL DELAY WAS REPORTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.8MM CALIBRATED DRILL BIT QC 250MM/ 95MM (PART NUMBER 03.113.024, LOT 3L79590, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.8MM CALIBRATED DRILL BIT QC 250MM/ 95MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Foreign Body In Patient; No Code Available

  MAUDE report 9904086 ↗
• InjuryMar 31, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020, WHILE DRILLING, THE TWO (2) DRILL BITS SPLIT, LEAVING TWO FRAGMENTS INSIDE THE PATIENT. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO SURGICAL DELAY WAS REPORTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM (PART NUMBER 03.113.024, LOT L203043, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Foreign Body In Patient; No Code Available

  MAUDE report 9904026 ↗
• MalfunctionJun 18, 2019Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION ON (B)(6) 2019, A CALIBRATED DRILL BIT WAS RETURNED WITH A MISSING COMPONENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.8MM CALIBRATED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8708304 ↗
• InjuryMar 16, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY FOR A TIBIA FRACTURE ON (B)(6) 2017 USING A TIBIA INTRAMEDULLARY (IM) NAIL, WITH ONE (1) 3.5MM VARIABLE ANGLE (VA) PROXIMAL TIBIA PLATE/ SCREWS TO REDUCE THE FRACTURE THE DRILL BIT BROKE. AFTER THE SURGEON HAD IMPLANTED THE IM NAIL, AND WAS PREPARING FOR THE PLATE/SCREW IMPLANTATION, AS HE WAS DRILLING THE PILOT SCREW HOLE THRU THE (VA) PLATE AND INTO THE TIBIA BONE, HE NOTED THAT HE HAD ENGAGED THE PREVIOUSLY IMPLANTED IM NAIL AND BROKE THE TIP OF THE DRILL BIT. ADDITIONAL IMAGES WERE TAKEN TO IDENTIFY THE LOCATION OF THE BROKEN TIP. TIP FRAGMENT WAS EASILY REMOVED. DUE TO THIS EVENT AND ADDITIONAL 5 MINUTES WAS ADDED TO OPERATING ROOM TIME. SURGERY WAS COMPLETED SUCCESSFULLY, AND PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: TIBIA INTRAMEDULLARY (IM) NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), 3.5MM VARIABLE ANGLE (VA) PROXIMAL TIBIA PLATE, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), LOCKING SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

  Patient problems: No Code Available

  MAUDE report 6411058 ↗