QFIX 72290125Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885556662632), received between Sep 26, 2019 and Apr 27, 2026 — classified as 17 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN MPFL PROCEDURE, ONE OF THE Q-FIX MINI KITS BROKE DURING DRILLING. THE DRILL WAS STUCK INSIDE THE MEDAL PART OF THE GUIDE, IT SPUN BUT DID NOT COME BACK OUT OF THE GUIDE, EVENTUALLY BREAKING WHERE THE METAL PART OF THE DRILL GUIDE MET THE WHITE HUB. WHEN THE DRILL WAS REMOVED, THE REMAINING PIECES WERE ALSO REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONALLY DRILLED BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25000706 ↗
• InjuryJul 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A BTB (BONE PATELLAR BONE) ACL RECONSTRUCTION FOR REVISION SURGERY, THE TIP OF THE Q-FIX MINI DRILL BROKE OFF WHILST DRILLING A HOLE FOR LET (LATERAL EXTRA TENODISIS) FIXATION. THE SURGEON HAD PLACED SOFT SILK (METAL) SCREWS FOR FEMORAL & TIBIAL FIXATION OF BTB GRAFT AND IT SEEMED THAT THE DRILL TIP SHEARED OFF AFTER MAKING CONTACT WITH THE SCREW. THE BIT OF METAL WAS LEFT IN THE PATIENT'S FEMUR AS IT COULD NOT BE REMOVED AND LOCATED ADJACENT TO THE METAL SCREW. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE TO DRILL AN ADDITIONAL BONE HOLE FURTHER DOWN FROM THE FIRST HOLE SITE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation; Rupture

  MAUDE report 17253182 ↗
• InjuryJul 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE QFIX MINI DRILL BIT BROKE OFF, THE SURGEON RECKONS IT HAD LODGED INSIDE THE HUMERAL SHAFT AND CANNOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN THE SAME BONE HOLE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS FINE.

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

  MAUDE report 15054620 ↗
• InjuryJun 28, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE QFIX DRILL BROKE INSIDE THE DRILL GUIDE; DRILLING WAS IN LINE WITH DRILL GUIDE. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847658 ↗
• InjuryNov 23, 2021Break; Break

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, INTERNAL TO PATIENT. WHEN THE 1.8MM Q-FIX MINI WAS USED TO DRILL, IT BROKE INSIDE OF THE PATIENT. THE BROKEN PIECE WAS NOT ABLE TO RETRIEVED WITHOUT MAKING A LARGE DEFECTS SO THE SURGEON DECIDED TO LEAVE IT IN. IT WAS NECESSARY TO DRILL AN ADDITIONAL BONE HOLE AS THE DRILL WAS UNABLE TO BE EXTRACTED FROM THE ORIGINAL BONE HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A N+S BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 12861674 ↗
• InjuryOct 25, 2021Break; Break

  IT WAS REPORTED THAT DURING THE ANCHOR DEPLOYMENT, THE DRILL OF THE DISPOSABLE KIT WAS BROKEN WHEN DRILLING. THE PIECES WERE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. THE BACK-UP DEVICE WAS USED IN THE ORIGINAL HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693729 ↗
• InjuryOct 24, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION PROCEDURE USING THE 1.8MM QFIX MINI, THE DRILL GOT JAMMED IN THE GUIDE AND BROKE AT THE PLASTIC DRILL STOPPER THAT PREVENTS DRILLING TOO DEEP. ALL MATERIAL WAS RETRIEVED FROM THE JOINT. THE PROCEDURE WAS FINISHED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12687043 ↗
• InjurySep 30, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THE 1.8 DRILL SNAPPED 1 CM AWAY FROM BLUE DRILL STOP. A DELAY LESS OR EQUAL THAN 30 MINUTES WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH S+N BACKUP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12557400 ↗
• MalfunctionSep 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE Q-FIX MINI DRILL BIT BROKE AND THE DISTAL TIP WAS BENT WHILE ATTEMPTING TO REMOVE THE BROKEN DRILL FROM THE DRILL GUIDE. IT WAS A PHYSICAL BREAKAGE, BUT IT DID NOT BREAK INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY WITH NON-SIGNIFICANT DELAY AND COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554472 ↗
• InjuryAug 20, 2021Break; Break

  IT WAS REPORTED THAT DURING A PATELLA TENDON RECONSTRUCTION USING 1.8 Q-FIX KIT, THE DRILL SNAPPED AT THE JUNCTION TO THE BLUE RUBBER STOPPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK UP DEVICE. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350656 ↗
• InjuryJul 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, SMALL METAL POWDER APPEARED WHEN DRILLING WITH THE Q-FIX MINI KIT. THE METAL POWDER WAS RETRIEVED FROM THE PATIENT THROUGH SUCTION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. A 15 MINUTES DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247857 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE DRILL BIT OF THE QFIX 1.8 MINI KIT SNAPPED INSIDE THE DRILL GUIDE, IT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132708 ↗
• InjuryMar 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE QFIX DRILL AND THE DRILL GUIDE WERE PUT TOGETHER CORRECTLY. THESE INSTRUMENTS WERE INSERTED INTO THE GLENOID BUT BEFORE ENGAGING WITH THE BONE, THE DRILL WAS TESTED TO SEE IF IT WAS ROTATING BY ACTIVATING THE DRILL BUT IT IMMEDIATELY SEIZED, LOCKED AND SNAPPED THE DRILL BIT. THE PRODUCT BREAK INSIDE THE PATIENT BUT THE PIECES WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT 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 11526827 ↗
• InjuryMar 9, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY WITH A QFIX 1.8 MINI SUTURE ANCHOR DISP KIT, THE DRILL WAS PLACED INTO THE GUIDE AND AFTER IT STARTED DRILLING, THE TORQUE SNAPPED THE DRILL SHAFT. THE PIECES WERE REMOVED, BUT THE DRILL SHAFT COULD NOT BE SEPARATED FROM THE GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF A DELAY OCCURRED DUE TO THE EVENT. 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 11448452 ↗
• InjuryJan 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY ,A 1.8MM Q-FIX DISPOSABLE KIT FAILED. AFTER THE DRILL GUIDE WAS DEPLOYED CORRECTLY AND TORQUE WAS APPLIED, THE DRILL STOP DISINTEGRATED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 11151967 ↗
• InjuryJan 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, A 1.8MM Q-FIX DISPOSABLE KIT FAILED. AFTER THE DRILL GUIDE WAS DEPLOYED CORRECTLY AND TORQUE WAS APPLIED, THE DRILL STOP DISINTEGRATED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 11151860 ↗
• InjuryJan 11, 2021Break; Break

  IT WAS REPORTED THAT DURING, A SHOULDER STABILIZATION/LABRAL REPAIR SURGERY, WHEN THE DRILL FROM THE DISPOSABLE Q-FIX KIT WAS INSERTED INTO THE DRILL GUIDE, IT GOT STUCK, IT DID NOT MAKE CONTACT WITH THE BONE. WHILE ATTEMPTING TO THE REMOVE THE DRILL FROM THE DRILL GUIDE, A PLASTIC COMPONENT FROM THE DRILL BROKE, ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 11151834 ↗
• InjuryOct 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY FOR BICEP TENODESIS, WHEN THE Q-FIX DRILL WAS INSERTED AND ADVANCED THROUGH THE DRILL GUIDE, IT BECAME LODGED IN THE GUIDE AND BROKE ABOVE THE GUIDE. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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; No Information

  MAUDE report 10660176 ↗
• InjuryAug 27, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE DISPOSABLE KIT FOR 1.8MM Q-FIX MINI SUTURE ANCHOR DRILL AND DRILL GUIDE WERE INSERTED INTO SHOULDER JOINT FOR BICEP TENODESIS AND AS DRILL WAS ADVANCED, DRILL BECAME LODGED IN GUIDE AND THE DRILL SNAPPED ABOVE THE GUIDE, CLOSE TO THE PLASTIC STOPPER; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462507 ↗
• InjuryAug 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE Q-FIX MINI BROKE IN 3 PIECES WHEN USING IT FOR THE FIRST TIME. A BLUE PIECE, PROXIMAL ROD AND DISTAL PART SNAPPED, THE LAST PIECE GOT STUCK IN THE DRILL GUIDE. ALL THREE PIECES WERE SUCCESSFULLY RECOVERED, THE EXTERNAL PIECES WERE RETRIEVED BY HAND. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO FURTHER 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 10426279 ↗
• MalfunctionFeb 4, 2020Material Separation; Material Separation

  IT WAS REPORTED ABOUT A DISPOSABLE KIT FOR 1.8MM Q-FIX MINI SUTURE ANCHOR THAT DURING A KNEE PROCEDURE WHEN DRILLING THE HOLE WITH DRILL AND DRILL GUIDE, THE DRILL DID NOT COME BACK OUT OF THE DRILL GUIDE. THEREFORE, IT WAS TRIED TO PULL IT OUT HARD AND AS A CONSEQUENCE, THE DRILL BIT CAME APART IN THREE PIECES AND COULD NOT BE ABLE TO BE REMOVED FROM THE DRILL GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING AN ADDITIONAL BONE HOLE. A BACK-UP DEVICE WAS AVAILABLE AND 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 Known Impact Or Consequence To Patient

  MAUDE report 9665165 ↗
• MalfunctionFeb 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN OPEN BICEPS TENODESIS, WHEN TRYING TO CLEAR THE BONE TUNNEL FOR Q-FIX TECHNIQUE BY RETRACTING AND PROGRESSING DRILL, THE LATTER WAS STUCK/FUSED TO THE DRILL GUIDE AND WAS UNABLE TO BE REMOVED FROM IT. ALTHOUGH THERE WAS NOT ANY FRAGMENTATION, THE PIECES BROKE INSIDE OF THE PATIENT. AFTER EASILY REMOVING ALL PIECES FROM THE PATIENT, A NEW DISPOSABLE DRILL KIT WAS OPENED AND USED, IN THE SAME BONE HOLE, TO COMPLETE THE PROCEDURE. SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9656957 ↗
• MalfunctionJan 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ABOUT A QFIX 1.8 MINI SUTURE ANCHOR THAT DURING A SHOULDER PROCEDURE THE DRILL BIT EXHIBITED TO BE BLUNT AND DIFFICULT TO DRILL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. THERE WERE NO PATIENT INJURIES AND 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 Known Impact Or Consequence To Patient

  MAUDE report 9592606 ↗
• MalfunctionSep 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPIC STABILIZATION THE DEVICE BROKE WHILST DRILLING THE FIRST HOLE. ALL DEVICE FRAGMENTS WERE RETRIEVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9124910 ↗