VALOR 4150011000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889797035545), received between Apr 4, 2022 and Nov 12, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 23538683 ↗
• MalfunctionNov 4, 2025Use of Device Problem; Use of Device Problem

  VALOR NAIL ALIGNMENT GIG IS OUT OF SPEC/HAS PLAY AND THEREFORE CAUSING SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462953 ↗
• MalfunctionNov 4, 2025Use of Device Problem; Use of Device Problem

  VALOR NAIL ALIGNMENT GIG IS OUT OF SPEC/HAS PLAY AND THEREFORE CAUSING SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462714 ↗
• MalfunctionOct 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT HAD A BROKEN SPRING INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425078 ↗
• MalfunctionMar 28, 2025Failure to Align; 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 21723946 ↗
• MalfunctionNov 25, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE CODE 44180025 DID NOT GUARANTEE THE SCREWS TIGHTENING AS IT WENT OFF WHEN IT WAS TENSIONED AND CODE 4150011000 DID NOT ALLOW THE CENTERING OF THE 2 PROXIMAL HOLES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY FREE-HAND-TECHNIQUE WITH FORCING THE SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771096 ↗
• MalfunctionJul 17, 2024Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE TARGET DEVICE JAMMED AND COULD NOT TURN TO NR 1, 2 OR 3. THE OPERATION WAS DELAYED APPROXIMATELY 20 MIN. THE SURGEON USED A HAMMER AND OTHER INSTRUMENTS TO RELEASE THE TRIGGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760679 ↗
• MalfunctionJun 11, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PIN/CLIP THAT PREVENTS THE GUIDES FROM ROTATING WAS BROKEN. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514156 ↗
• 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 17241153 ↗
• MalfunctionMay 16, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE VALOR TARGETING JIG MISSED BOTH HOLES IN THE NAIL IN POSITION 3. THERE WAS A SLIGHT ISSUE WITH THE TARGETING JIG (DEEMED USABLE) AND DUE TO HIGH DEMAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937600 ↗
• 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 16704404 ↗
• MalfunctionApr 7, 2023Break; Fracture; Break; Fracture

  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 16704397 ↗
• 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 16704382 ↗
• MalfunctionNov 28, 2022Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED THAT THE VALOR NAIL EXTERNAL OUTRIGGER WAS DISTORTED AND THE VALOR NAIL WOULD NOT ALIGN APPROPRIATE WITH THE DRILL GUIDE HOLES WHEN CORRECTLY ASSEMBLED. IT WAS NOTICED UPON SURGEON INSPECTION AND ATTEMPT TO CHECK THE DRILL GUIDES LINED UP WITH THE SCREW HOLES IN THE NAIL, VISUALLY IT WAS EVIDENT THAT THEY WERE INCONGRUENT. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15872285 ↗
• 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 14000501 ↗