VALOR 4150011002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889797035552), received between Apr 4, 2022 and Mar 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  "THE VALOR JIG IS FAILING TO ALIGN FOR SCREW PLACEMENT " THE INCIDENT OCCURRED TODAY. SURGERY WAS COMPLETED BUT IT TOOK LONGER & WE HAD TO FREEHAND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723988 ↗
• MalfunctionJun 30, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT A PATIENT HAD AN ALIGNMENT ISSUE REGARDING THE OUTRIGGER-SUBTALAR ALIGNMENT. THE PATIENT SUFFERED FROM CHARCOT ARTHROPATHY AND REQUIRED AN ANKLE FUSION VIA A HINDFOOT NAIL FOR HIS PROCEDURE. NO MEDICAL INTERVENTION REPORTED DURING THIS EVENT. YES, A 10-MINUTE DELAY OCCURRED IN ATTEMPTING TO RE-ALIGN THE SCREW TRAJECTORY TO INSERT INTO THE NAIL. CONSEQUENTLY, THIS ATTEMPT FAILED AND THE SURGEON RESORTED TO USING CANNULATED SCREWS. ADDITIONAL CONSEQUENCES ARE TO BE DETERMINED. 6 AND 12-MONTH POST-OPERATIVE FOLLOW-UPS WILL INDICATE WHETHER THE ANKLE HAS SUCCESSFULLY UNSUCCESSFULLY FUSED AND HEALED. SURGEON IMPLANTED CANNULATED SCREWS OUTSIDE AND NEXT TO THE INTRAMEDULLARY NAIL. NO PATIENT LABELS ARE AVAILABLE FOR REVIEW. NO RADIOGRAPHIC IMAGES FROM PRE-OP, PERI-OP AND/OR POST-OP AVAILABLE TO PROVIDE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241152 ↗
• MalfunctionApr 7, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE WELDED SCREWS OFTEN BREAK AND THEN THERE ISN¿T ENOUGH TENSION IN THE HANDLE TO GET THE ADAPTOR OFF. THE TARGETING GUIDE SLOWLY BECOMES OUT OF ALIGNMENT DUE TO THE HEAT FROM STERILIZATION AND THE POUNDING AND TORQUE OF THE JIG . SECONDLY, SOME GREEN LETTERS ON THE JIG AND SOME WITH ORANGE WHEN IN POSITION 3 MISS THE SUBTALAR SCREW EVERY TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16702170 ↗
• MalfunctionNov 16, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE JIG WAS NOT ALIGNING CORRECTLY. THE SURGICAL TEAM DID AN ALIGNMENT CHECK BEFORE THE CASE STARTED AND THE DRILL WAS NOT PROPERLY GOING THROUGH THE NAIL WHEN LOCKED IN ¿POSITION 3¿ AND ATTEMPTING THE LEFT SUBTALAR SCREW. THE OUTRIGGER GUIDE DID NOT SEEM TO AIM THE DRILL DIRECTLY THROUGH THE CENTER OF THE HOLE, IT WAS COMING INTO CONTACT WITH THE NAIL ITSELF, JUST ABOVE THE HOLE. THE SURGEON FIDDLED AROUND WITH IT AND MANAGED TO GET IT TO WORK OUTSIDE OF THE PATIENT BUT WHEN INSIDE THE PATIENT THE ALIGNMENT WAS DISRUPTED AGAIN AND THE SURGEON WAS NOT ABLE TO PLACE THE SUBTALAR SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15805929 ↗
• MalfunctionApr 4, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE TARGETING GUIDE WAS NOT MOVING APPROPRIATELY INTO THE THIRD POSITION, IT WOULD NOT CLICK INTO PLACE. THE SUBTALAR GUIDE ALSO HAS ISSUES WITH THE INNER LOCKING KNOB SLIDING IN AND OUT. SUBTALAR SCREW MISSED THE HOLE IN THE NAIL. IT HAD TO BE TAKEN OUT AND INSERTED FREE-HAND DUE TO JIG NOT IN CORRECTION PLACE.

  Patient problems: Insufficient Information

  MAUDE report 14000502 ↗