NA 03.133.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982269614), received between Apr 24, 2020 and Jul 27, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037174 ↗
• MalfunctionNov 13, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED DURING THE SURGERY, THE USF 1 CONSIGNMENT EQUIPMENT WAS USED AND WHEN THE DOCTOR ASKED FOR THE DRILL BITS TO FIX THE PLATE, THEY WERE VERY DIFFICULT TO ENTER THE PATIENT'S BONE, REQUESTING A CHANGE OF DRILL BIT. WITH EACH DRILL BIT THAT HE PASSED, THE SAME PROBLEM OCCURRED, CAUSING A DELAY. THE SURGERY WAS CARRIED OUT. IT ENDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542794 ↗
• MalfunctionNov 13, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED DURING THE SURGERY, THE USF 1 CONSIGNMENT EQUIPMENT WAS USED AND WHEN THE DOCTOR ASKED FOR THE DRILL BITS TO FIX THE PLATE, THEY WERE VERY DIFFICULT TO ENTER THE PATIENT'S BONE, REQUESTING A CHANGE OF DRILL BIT. WITH EACH DRILL BIT THAT HE PASSED, THE SAME PROBLEM OCCURRED, CAUSING A DELAY. THE SURGERY WAS CARRIED OUT. IT ENDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542780 ↗
• MalfunctionFeb 4, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE 2.5 DRILL HAD NO EDGE. IT WAS DELIVERED TO LIBRADO OF CENTRAL, WAS MADE CHANGE OF THE BIT AND WAS DELIVERED TO HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 21302520 ↗
• MalfunctionJan 22, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY, THE 135 MM 2.5 DRILL BIT IS BROKEN WITHOUT AFFECTING THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.5 DRILL BIT QC 135 45 CALIBRATION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552157 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT BECAME JAMMED INSIDE OF THE DRILL GUIDE. SURGERY WAS DELAYED FOR APPROXIMATELY 2 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DRILL BIT. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT QC 135MM 45MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694927 ↗
• MalfunctionJan 26, 2023Failure to Cut; Failure to Cut

  THE 2.5 DRILL BIT WENT DULL QUICKLY. THE PATIENT DID HAVE VERY DENSE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249916 ↗
• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS AND SCREWS BROKE WHILE DRILLING AROUND A FEMORAL PROSTHESIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED; IT IS UNKNOWN WHETHER THEY WERE EASILY REMOVED WITHOUT FURTHER INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.5MM DRILL BIT QC 135MM 45MM CALIBRATION. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15805002 ↗
• InjurySep 17, 2021Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT ON (B)(6) 2021, THE 2.5MM DRILL BIT/QUICK COUPLING DRILL BIT BROKE DURING A REVISION OF INTERNAL FIXATION LEFT TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A GOOD PATIENT OUTCOME. VERY LITTLE SURGICAL DELAY WAS EXPERIENCED. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT QC 135MM STER 45MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12487715 ↗
• MalfunctionOct 27, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE NEW DRILL BITS WERE DULL. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT QC 135MM 45MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10740664 ↗
• InjuryApr 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE DRILL BIT BROKE DURING DRILLING. THE BROKEN PIECE REMAINED IN THE BONE AND ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9996425 ↗