Q-FIX 72205859Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556885390), received between Nov 21, 2025 and Feb 20, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• MalfunctionFeb 20, 2026Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ATFL PROCEDURE, AFTER TWO (2) UNITS OF A 1.8MM Q-FIX ASA W/1 MT BL WERE IMPLANTED AND THE SHAFTS WERE REMOVED FROM BONE HOLE, THE MINITAPE WAS TANGLED AROUND THE SHAFT, AND IT COULDN'T BE REMOVED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400862 ↗
• MalfunctionFeb 20, 2026Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ATFL PROCEDURE, AFTER TWO (2) UNITS OF A 1.8MM Q-FIX ASA W/1 MT BL WERE IMPLANTED AND THE SHAFTS WERE REMOVED FROM BONE HOLE, THE MINITAPE WAS TANGLED AROUND THE SHAFT, AND IT COULDN'T BE REMOVED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400813 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A REVISION MPFL RECONSTRUCTION PROCEDURE, IT WAS NOTICED THAT TWO (2) Q-FIX ANCHOR REMAINED IN-SITE AFTER IT WAS DEPLOYED, BUT THE LOADED MINITAPE SUTURE TAILS WERE SEVERED IN HALF ONCE INSERTER AND GUIDE WERE REMOVED. THE SUTURES WERE REMOVED FROM PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT ON AN ADDITIONAL DRILLED BONE HOLE, LEAVING A VOID IN THE PATIENT. PATIENT IS HEALTHY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Joint Laxity; Perforation

  MAUDE report 24394942 ↗
• MalfunctionNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A QUADRICEPS TENDON REPAIR, ONE (1) UNIT OF A 1.8MM Q-FIX ASA W/1 MT BL WAS PULLED OUT OF THE BONE AFTER BEING DEPLOYED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A 15 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONAL DRILLED BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23633858 ↗
• MalfunctionNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A QUADRICEPS TENDON REPAIR, TWO (B)(4) UNITS OF A 1.8MM Q-FIX ASA W/1 MT BL WAS PULLED OUT OF THE BONE AFTER BEING DEPLOYED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A 15 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONAL DRILLED BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23617175 ↗