Q-FIX 72205693Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556890745), received between Jun 11, 2025 and Jun 1, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ATFL SURGERY, THE Q-FIX ULTRA ANCHOR GOT PULLED OUT FROM THE BONE AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S&N BACK-UP DEVICE IN ANOTHER BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25349147 ↗
• MalfunctionMay 28, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A POST TIB REPAIR WITH INTERNAL BRACING PROCEDURE, THE Q-FIX ULTRA COULDN'T BE DEPLOYED. USING A 1.25 MM DRILL PIN TO LOCATE AT THE TARGETED BONE, THEN A 2.9MM CANNULATED DRILL BIT WAS USED TO CREATE INITIAL HOLE WITH THE EXTREMITIES GUIDE. THE SURGEON PLACED THE Q-FIX ULTRA IN THE INITIAL HOLE AND STARTED TO DEPLOY BY TWISTING THE KNOB OF THE IMPLANT, TILL 2 POP SOUND WAS HEARD, BUT IMPLANT DIDN'T DEPLOY IN THE BONE AND IT FORMED THE BALL IN THE METAL SHEALTH INSTEAD, THEN THE SUTURE WAS RELEASED AND THE IMPLANT WAS REMOVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO ANCHOR WAS IMPLANTED, WHICH RESULTED IN A VOID LEFT IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25326239 ↗
• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE (1) Q-FIX ULTRA FELL OUT OF THE BONE. AN UNKNOWN BACKUP DEVICE WAS USED IN A NEWLY DRILLED BONE HOLE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23364350 ↗
• MalfunctionSep 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, FOUR (4) Q-FIX ULTRA ANCHORS COULD NOT DEPLOY AFTER INSERTION INTO THE PRE-DRILLED BONE HOLE. THE PROCEDURE WAS COMPLETED PLACING A S+N BACKUP DEVICE INTO AN ADDITIONAL DRILLED BONE HOLE. THERE WAS A SIGNIFICANT SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23075511 ↗
• MalfunctionJun 11, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SPHERE OF THE Q-FIX ULTRA WOULD NOT GET STUCK SO IT REMAINED IN THE GUIDE. AN ADDITIONAL BONE HOLE WAS REQUIRED TO USE THE UNKNOWN BACK UP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22184164 ↗