NA 03.045.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982302472), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, TWO GUIDE ROD RULERS FROM THE ANS SET AND FLEXIBLE REAMERS WERE COMBINED TO INACCURATELY MEASURE TIBIAL NAIL LENGTH. MEASURING DEVICE 351.717 WAS COMBINED WITH ELONGATION TUBE 03.045.036. THIS EVENT ADDED 10 MINUTES TO THE SURGERY TO REMOVE THE INCORRECT NAIL AND REPLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TUBE F/DIRECT MEASURING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923807 ↗