Asnis 45-30005SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540534217), received between May 2, 2018 and Aug 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE HOLLOW DRILL WAS DAMAGED DUE TO DRILLING WITH FLEXURE."

  Patient problems: Insufficient Information

  MAUDE report 22805305 ↗
• MalfunctionJun 26, 2024Break; Fracture; Material Deformation; Material Twisted/Bent; Break; Fracture; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THE DRILL TIP TWISTED AND BROKE WHEN THE BONE WAS HARD AND FORCE WAS APPLIED DURING DRILL USE. A PORTION OF THE DAMAGED DRILL TIP IS LEFT IN THE PATIENT. THE OTHER DRILL TIP WAS THEN USED AND THE PROCEDURE CONTINUED WITHOUT PROBLEMS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19620255 ↗
• MalfunctionApr 27, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "INSTRUMENT SET: ASNIS MICRO 2.0/3.0 CANNULATED SCREWS. WHILE DRILLING WITH THE 2.1MM DRILL OVER THE 1.2MM WIRE THAT WAS INSIDE THE PATIENT THE DRILL EXPLODED AND BROKE OFF INSIDE THE PATIENT. THE METAL FROM THE DRILL CAUSED SHARDS TO BREAK OFF INTO THE DRILL GUIDE CAUSING IT TO BE UNUSABLE AND EXTRA TIME WAS SPENT REMOVING THE BROKEN DRILL FROM THE PATIENT. UPDATE ON 07 APR 2023: 5 MINUTE DELAY TO EXTRACT DRILL/DEBRIS, ALL DEBRIS WAS REMOVED, PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING A SCREW IN THE DRILL HOLE AFTER REMOVING DEBRIS FROM DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827305 ↗
• MalfunctionFeb 6, 2023Material Frayed; Material Deformation; Material Frayed; Material Deformation

  AS REPORTED: "STRYKER DRILL BIT WAS NOTED BY DOCTOR TO HAVE FRAYED/UNTWISTED DURING USE. DRILL BIT WAS REMOVED FROM THE STERILE FIELD AND SERVICE COORDINATOR NOTIFIED TO INITIATE PRODUCT FAILURE PROCESS." IT IS UNKNOWN IF THERE WAS ANY DEBRIS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16308855 ↗
• MalfunctionMay 2, 2018Bent; Break

  A CANNULATED DRILL BIT COD.45-0005S BROKE DURING THE OSTEOSYNTHESIS OF TIBIAL MALLEOLUS FRACTURE. DURING THE PERFORATION OF THE MALLEOLUS, USING THE DEDICATED GUIDEWIRE, A FRAGMENT OF THE HELIOID PORTION OF THE DRILL WAS DETACHED FROM IT AND REMAINED IN SITU. ONCE THE BUR HAS BEEN REMOVED FROM THE MALLEOLUS, THE DAMAGED HELICAL PORTION WAS SLIGHTLY BENT. IT WAS NOT POSSIBLE TO REMOVE THE FRAGMENT, BUT THIS DID NOT PREVENT THE OSTEOSYNTHESIS OF THE MALLEOLUS WITH AN ASNIS MICRO SCREW D.3.0, AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481295 ↗