Valor® 415101125RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420125613), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 4, 2024Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam

  AS REPORTED: "THE INTERNAL COMPRESSION SCREW WOULD NOT ENGAGE INTO THE CALC COMPRESSION SCREW AND WOULD NOT BACK OUT OF THE NAIL. THE INTERNAL COMPRESSION SCREW COLD WELDED INSIDE THE NAIL. THE TARGETING GUIDE WAS REMOVED FROM THE NAIL TO REMOVE THE INTERNAL COMPRESSION SCREW BUT WERE UNABLE TO EITHER PROGRESS OR REMOVE THE INTERNAL COMPRESSION SCREW. DEVICE WAS STILL ABLE TO ACHIEVE DESIRED FUSION. WE WERE NOT ABLE TO UTILIZE THE INTERNAL COMPRESSION OF THIS PRODUCT. THE APPOSITION OF THE ANKLE JOINT HAD OBTAINED ADEQUATE FUSION FROM THE JOINT DEBRIDEMENT. THE SURGEON PREFERRED ADDITIONAL FUSION WITH THE INTERNAL COMPRESSION WHICH WE WERE UNABLE TO UTILIZE. THE INTERNAL COMPRESSION SCREW WAS LEFT COLD WELDED IN THE PLANTAR/BOTTOM ASPECT OF THE NAIL." IT WAS ADDITIONALLY REPORTED THAT THERE WAS A 35 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848801 ↗