Q-FIX 25-1811Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556724620), received between Aug 20, 2021 and Mar 26, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, A DISPOSABLE XL 1.8MM Q-FIX DRILL GUIDE WAS INSERTED PERCUTANEOUSLY INTO THE JOINT. THE CONVENTIONAL 1.8MM DRILL BIT WAS USED TO PREPARE THE ANCHOR HOLE IN THE GLENOID. A 1.8MM Q-FIX KNOTLESS ALL SUTURE ANCHOR WAS DEPLOYED IN A ROUTINE MANNER. AS THE ANCHOR HANDLE WAS BEING REMOVED FROM THE DRILL GUIDE, WHICH STAYED IN THE JOINT, THE TRANSFER SUTURE RUPTURED APPROXIMATELY 5-10MM FROM THE ANCHOR BALL. THIS RUPTURE MADE THE ANCHOR UNUSABLE AS THE REPAIR SUTURE COULD NOT BE SHUTTLED THROUGH THE ANCHOR'S INTERNAL LOCKING MECHANISM. A 1.8MM Q-FIX DISPOSABLE KIT XL (REF: 25-1811) WAS USED TO PREPARE THE INSERTION SITE AND ALL THE SITE WAS CLEARD OF ALL DEBRIS PRIOR TO THE INSERTION. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A CONMED Y-KNOT, 1.3MMCOMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702562 ↗
• InjurySep 16, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON HAD COMPLETED A LATARJET PROCEDURE AND WAS USING A Q-FIX KNOTLESS ANCHOR TO COMPLETE THE LABRAL REPAIR. THE SURGEON WAS ATTEMPTING TO DRILL INTO THE GLENOID WITH THE Q-FIX DRILL, 3-4 ATTEMPTS WERE MADE AS EACH TIME HE DRILLED AND TRIED TO PLACE THE ANCHOR BUT IT WAS NOT POSSIBLE TO GET THE ANCHOR FLUSH WITH THE DRILL GUIDE. ON THE LAST ATTEMPT, WHEN THE SURGEON PULLED THE DRILL OUT OF THE DRILL GUIDE, HE NOTED THAT AROUND 2CM OF THE DRILL HAD SNAPPED OFF INSIDE THE PATIENTS GLENOID. ATTEMPTS WERE MADE TO RETRIEVE THE DRILL BUT AS IT WAS FLUSHED WITH THE BONE IT COULD NOT BE PULLED OUT. THE PIECE OF THE DRILL WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP WAS USED IN AN ADDITIONAL DRILLED HOLE. NO VOIDS WERE LEFT AS THE PIECE OF BROKEN DRILL REMAINS IN THE PATIENT. THERE WAS A POST OPERATIVE XRAY DONE TO VISUALIZE THE DRILL PIECE. THE SURGEON DID NOT HAVE PLANS TO REMOVE THE BROKEN PIECE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23063026 ↗
• MalfunctionNov 7, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A Q-FIX DRILL FROM THE DISPOSABLE KIT GOT STUCK INTO THE DRILL GUIDE AND SNAPPED, IT CAME OFF FROM THE BLACK POINT OF THE DRILL. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743511 ↗
• InjuryMar 8, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DRILL OF THE DISPOSABLE KIT HIP WAS BROKEN. THE DEVICE BROKE ON INSERTION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690871 ↗
• InjurySep 22, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DRILL BROKE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THREE MINUTES OF DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515894 ↗
• InjuryAug 20, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DRILL FROM THE 1.8 Q-FIX SUTURE ANCHOR DISPOSABLE KIT BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351074 ↗