NA 310.430Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982186621), received between Mar 14, 2018 and Nov 24, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL FEMORAL FRACTURES. DURING THE SURGERY, THE DRILL BIT IN QUESTION WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635716 ↗
• MalfunctionDec 15, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BIT IN QUESTION WAS DAMAGED DUE TO TENSION OF THE BONE. FRAGMENTS WERE GENERATED AS THE BIT BROKE INSIDE OF THE BONE , BUT THEY WERE ABLE TO BE EXTRACTED FROM THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.3MM DRILL BIT QC/221MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986560 ↗
• MalfunctionAug 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, ONE DRILL BIT BROKE INSIDE OF THE BONE, AND IT WAS NOT POSSIBLE TO EXTRACT THE FRAGMENT. THREE OTHER DRILL BITS WERE FOUND TO BE DULL DURING THE SAME PROCEDURE. THERE WAS A TOTAL SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 4.3MM DRILL BIT QC/221MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208936 ↗
• InjuryMar 14, 2018Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING KNEE SURGERY ON (B)(6) 2018, THE SURGEON WAS REMOVING A NON-SYNTHES PLATE TO REPLACE IT WITH A SYNTHES PLATE 4.5MM TI BROAD LOCKING COMPRESSION PLATE (LCP). WHEN SURGEON WAS USING THE DRILL BIT TO MAKE THE HOLES FOR THE SCREWS, THE DRILL BIT BROKE INSIDE THE PATIENT AND A FRAGMENT WAS LEFT INSIDE THE PATIENT. THE SURGEON INDICATED THAT THE DRILL BIT BROKE BECAUSE IT HIT A PREVIOUSLY IMPLANTED SCREW. THERE WAS NO SURGICAL DELAY REPORTED. CONCOMITANT DEVICES REPORTED: NON-SYNTHES PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1), 4.5MM TI BROAD LCP® PLATE (PART #: 426.641, LOT #: UNKNOWN, QUANTITY: 1), SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7338560 ↗