Q-FIX 25-1810Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556724613), received between Jul 18, 2020 and May 28, 2025 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A DRILL BIT OF THE DISPOSABLE KIT FOR 1.8MM BROKE DURING CHANNEL PREPARATION. ALL THE COMPONENT WERE REMOVED FROM THE JOINT. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE, AND THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095962 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A STABILIZATION CASE WHEN THE SURGEON PUT THE DRILL GUIDE OF THE DISPOSABLE SHOULDER Q-FIX KIT IN PLACE AND STARTED TO DRILL THE HOLE, THE DRILL BIT BROKE AT THE DISTAL METAL/PLASTIC JUNCTION. EVERYTHING CAME OUT EASILY AND NOTHING WAS STUCK IN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279764 ↗
• InjuryAug 9, 2024Break; Break

  IT WAS REPORTED THAT, DURING A MPFL RECONSTRUCTION, WHEN SURGEON WAS DRILLING HARD BONE IN THE SUPERIOR PATELLA, THE TIP OF THE DRILL FROM THE KIT FOR SHOULDER Q-FIX SNAPPED INSIDE THE BONE. THE TIP WAS LEFT IN SITU. AFTER THE RECONSTRUCTION, A SCOPE WAS PERFORMED BUT DRILL WAS NOT IN THE JOINT. AN II IMAGE SHOWED THE BROKEN DRILL BIT IN THE SUPERIOR POLE OF THE PATELLA. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 19950177 ↗
• InjuryJan 2, 2023Break; Break

  IT WAS REPORTED THAT DURING AN OPEN ELBOW REPAIR, WHEN SURGEON STARTED DRILLING, THE Q-FIX DRILL BIT GOT STUCK IN THE DISTAL TIP OF THE DRILL GUIDE AND RESULTED IN THE DRILL BIT SNAPPING AND BREAKING. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 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 16082625 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE Q-FIX GUIDE WAS INSERTED AND BEGAN TO DRILL WITH THE ACCOMPANIED DRILL BIT FROM THE DISPOSABLE KIT. THERE WASN'T SUCCESS DRILLING THE PILOT HOLE SINCE THE DRILL BIT BROKE. HOWEVER, NOTHING BROKE OFF INTO THE PATIENT'S SHOULDER. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE USE IN A NEW DRILLED BONE HOLE . THIS RESULTED IN A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation; Rupture

  MAUDE report 14455269 ↗
• InjuryDec 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE 'QFIX DRILL' SNAPPED IN HALF WHEN DRILLING. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112634 ↗
• InjurySep 14, 2021Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DRILL OF THE SHOULDER Q-FIX KIT WAS NOT DRILLING CORRECTLY AND WHEN TRYING TO PUT IN THE ANCHOR, IT BENT. THEN RE-DRILLED ONCE, MAKING ANOTHER PILOT HOLE FOR THE IMPLANT, USING THE SAME DRILL HE THEN TRIED TO RE-INSERT THE ORIGINAL IMPLANT AND AGAIN THIS FAILED TO ENGAGE WITH THE DRILL SLEEVE, CAUSING THE ANCHOR SHAFT TO BEND AND BECOME DAMAGED, MAKING IT UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 12472042 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, SOME METAL POWDER OF THE Q-FIX KIT DETACHED FROM THE DRILL WHEN DRILLING. PIECES WERE REMOVED FROM THE PATIENT WITH SUCTION. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445029 ↗
• InjuryAug 30, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A MPFLR USING THE QFIX SUTURE ANCHOR KIT, WHILE DRILLING THERE WAS RESISTANCE AND WHEN TRYING TO REMOVE THE DRILL, IT BECAME STUCK IN THE GUIDE. GUIDE AND DRILL HAD TO BE REMOVED TOGETHER FROM PATIENT AND A STIFFNESS OF THE DEVICES WAS NOTICED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND A NEW HOLE WAS DRILLED USING A BACK-UP DRILL AND GUIDE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 12385833 ↗
• MalfunctionMar 9, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A MPFL RECONSTRUCTION SURGERY USING THE "1.8MM Q-FIX ANCHOR DISPOSABLE KIT"; THE DRILL WAS INSERTED INTO THE DRILL GUIDE AND DRILLED THE HOLE. THE DRILL DID NOT COME BACK OUT OF THE DRILL GUIDE. IT SEEMED TO HAVE JAMMED INTO THE DRILL GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY SIGNIFICANT USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448953 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT DURING SHOULDER SCOPE PROCEDURE, TWO (2) DISPOSABLE KITS SHOULDER Q-FIX BROKE WHILE DRILLING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178757 ↗
• InjuryDec 4, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE DRILLING A QFIX 1.8 PILOT HOLE, THE DRILL BIT BROKE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944402 ↗
• InjuryAug 14, 2020Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY PROCEDURE, THE DRILL BROKE INSIDE THE PATIENT BUT THE PIECES WERE SUCCESSFULLY REMOVED. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10407957 ↗
• InjuryJul 18, 2020Break; Break

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE Q FIX BROKE WHEN IT WAS BEING DRILLED INTO THE PATIENT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10293082 ↗