VALOR 4150011004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889797035576), received between Sep 9, 2021 and Mar 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 25, 2026Fracture

  VALOR NAIL INSERTED BROKE, NO DELAYS IN CASE, ALL PARTS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690383 ↗
• MalfunctionNov 12, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A VALOR TARGETING HANDLE AND GUIDE BECAME STUCK TOGETHER WHILE BEING ASSEMBLED IN THE WAREHOUSE. THE SALES REPRESENTATIVE NOTED THAT THE GUIDE COULD NOT BE DETACHED FROM THE HANDLE AFTER PLACEMENT IN THE INSTRUMENT TRAY. BOTH COMPONENTS WERE BRAND NEW AND HAD NOT BEEN USED IN ANY SURGICAL PROCEDURES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538657 ↗
• MalfunctionSep 9, 2021Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  IT WAS REPORTED THAT THE NAIL CONNECTOR WOULD NOT ENGAGE NAIL TARGETING GUIDE CORRECTLY. IT SEEMED LIKE THE SPRING IN THE TRIGGER HANDLE MAY HAVE BEEN MISSING. THE 3 POSITIONS WOULD NOT LOCK INTO PLACE. THE SURGEON HAD TO USE THE PERFECT CIRCLE TECHNIQUE AND ABORT THE TARGETING GUIDE. A BACK UP DEVICE WAS NOT AVAILABLE. INCREASED OR TIME BY 45MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446190 ↗