NA 1806-6167Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540510037), received between May 11, 2018 and Feb 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  AS REPORTED: "THE EXTRACTION OF 4.0CCS WAS DIFFICULT, THE SCREW HEAD WAS REMOVED AND A CONICAL EXTRACTOR SMALL WAS USED, BUT THE TIP BROKE OFF AND REMAINED IN THE SCREW. THE INSIDE OF THE CROWN DRILL WAS CLOGGED. FINALLY, ALL EXTRACTION WAS COMPLETED".

  Patient problems: Insufficient Information

  MAUDE report 21368805 ↗
• MalfunctionJun 18, 2024Naturally Worn; Naturally Worn

  AS REPORTED: "CASE: REMOVAL OF METAL WORK (SYNTHES BLADE PLATE) WITH TIMEX KIT. REVISE USING ALPHA ANTEGRADE NAIL. IT WAS REPORTED THAT ALL THE CROWN DRILLS WERE BLUNT. ANOTHER COMPANY¿S KIT HAD TO BE OPENED TO REMOVE THE BROKEN SCREWS FROM THE BLADE PLATE. THE RECON DRILL AND SCREW WERE INSERTED INTO POSITION B, HOWEVER WHEN IT CAME TO POSITION A THE DRILL AND SCREW MISSED THE NAIL. THE SURGEON HAD TO DRILL AND ADVANCE THE SCREW FREE HAND WITHOUT THE USE OF THE TARGETING ARM. THE PROCEDURE LIKELY TOOK LONGER AND THE TEAM HAD TO OPEN SEVERAL ADDITIONAL KITS - ANOTHER COMPANY¿S SCREW REMOVAL KIT, ANOTHER COMPANY¿S CANNULATED DRILL KIT, AND STRYKER¿S ASNIS 6.5MM CANNULATED SCREW KIT. I WOULD ESTIMATE AROUND 20-30 MINUTES FOR THE TIMEX PORTION, AND 30-45 MINUTES FOR THE RECON SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563802 ↗
• MalfunctionMay 11, 2018Break; Material Fragmentation

  DURING A HARDWARE REMOVAL OF ASNIS III 4.0 MM CANNULATED SCREWS WE WERE USING A COMICAL DRILL ( REF# (B)(4) LOT# 1806-6167) DUE TO BONE GROWTH AROUND THE SCREW HEAD. BONE BECAME WEDGED IN THE DRILL WITH THE SCREW AND THE SCREW BROKE. THE SCREW BECAME STUCK IN THE DRILL ALONG WITH BONE. UPON REMOVING THE CONICAL DRILL AND NOTICING THE SCREW HEAD WAS GONE. BECAUSE OF THE BROKEN SCREW HEAD DR. HAD TO LEAVE THE REMAINING PORTION OF THE SCREW IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7507099 ↗