NA 310.44Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982186645), received between Mar 22, 2024 and Sep 11, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT DAMAGED/WORN DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025105 ↗
• MalfunctionMar 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 12-SEPTEMBER-2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WOULD NOT CUT AS INTENDED. THE DRILL BITS DID NOT PASS THROUGH THE BONE, CAUSING OVERHEATING AND A DELAY IN REDUCTION. NO FURTHER INFORMATION IS AVAILABLE. UPON EXAMINATION OF RETURNED PRODUCTS ON FEBRUARY 21, 2024, IT WAS NOTED THAT AN ADDITIONAL DRILL BIT WAS DULL. THIS REPORT IS FOR ONE 4.5MM DRILL BIT/QC/145MM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959106 ↗