NA 1806-0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540196408), received between Sep 13, 2021 and Jun 1, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Incorrect Measurement; Incorrect Measurement

  AS REPORTED: "DURING SURGERY, THE SURGEON NOTICED A DISCREPANCY BETWEEN THE LENGTH MEASUREMENT USING A SCALED DRILL AND THE LENGTH GAUGE (DIFFERENCE APPROX. 4MM). AFTER CHECKING IN THE STERILIZATION DEPARTMENT AND COMPARISON WITH TWO OTHER REFERENCES, THIS ERROR APPEARS TO BE CONFIRMED AND A COMPARATIVELY LONGER LENGTH WAS DETERMINED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038477 ↗
• MalfunctionJun 1, 2023Incorrect Measurement; Incorrect Measurement

  AS REPORTED: "DURING SURGERY, THE SURGEON NOTICED A DISCREPANCY BETWEEN THE LENGTH MEASUREMENT USING A SCALED DRILL AND THE LENGTH GAUGE (DIFFERENCE APPROX. 4MM). AFTER CHECKING IN THE STERILIZATION DEPARTMENT AND COMPARISON WITH TWO OTHER REFERENCES, THIS ERROR APPEARS TO BE CONFIRMED AND A COMPARATIVELY LONGER LENGTH WAS DETERMINED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038275 ↗
• MalfunctionMay 31, 2023Incorrect Measurement; Incorrect Measurement

  AS REPORTED: "DURING SURGERY, THE SURGEON NOTICED A DISCREPANCY BETWEEN THE LENGTH MEASUREMENT USING A SCALED DRILL AND THE LENGTH GAUGE (DIFFERENCE APPROX. 4MM). AFTER CHECKING IN THE STERILIZATION DEPARTMENT AND COMPARISON WITH TWO OTHER REFERENCES, THIS ERROR APPEARS TO BE CONFIRMED AND A COMPARATIVELY LONGER LENGTH WAS DETERMINED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034777 ↗
• MalfunctionMay 30, 2023Incorrect Measurement; Incorrect Measurement

  AS REPORTED: "DURING SURGERY, THE SURGEON NOTICED A DISCREPANCY BETWEEN THE LENGTH MEASUREMENT USING A SCALED DRILL AND THE LENGTH GAUGE (DIFFERENCE APPROX. 4MM). AFTER CHECKING IN THE STERILIZATION DEPARTMENT AND COMPARISON WITH TWO OTHER REFERENCES, THIS ERROR APPEARS TO BE CONFIRMED AND A COMPARATIVELY LONGER LENGTH WAS DETERMINED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025965 ↗
• MalfunctionMay 30, 2023Incorrect Measurement; Incorrect Measurement

  AS REPORTED: "DURING SURGERY, THE SURGEON NOTICED A DISCREPANCY BETWEEN THE LENGTH MEASUREMENT USING A SCALED DRILL AND THE LENGTH GAUGE (DIFFERENCE APPROX. 4MM). AFTER CHECKING IN THE STERILIZATION DEPARTMENT AND COMPARISON WITH TWO OTHER REFERENCES, THIS ERROR APPEARS TO BE CONFIRMED AND A COMPARATIVELY LONGER LENGTH WAS DETERMINED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025752 ↗
• MalfunctionSep 13, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THE DEPTH GAUGE WAS BROKEN WHILE MEASURING WITH THE T2 DEPTH GAUGE LONG TO INSERT THE DISTAL LOCKING SCREW. IT WAS AS IF THE THIN TIP HAD COME LOOSE FROM THE THICKER PART IN FRONT OF IT. THE BROKEN PART WAS NOT RETRIEVED FROM THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12459276 ↗