Q-FIX 72205884Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00885556901700), received between Dec 31, 2024 and Jun 27, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2026Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, AFTER THE SUTURE ANCHOR WAS IMPLANTED, THE MINITAPE OF Q-FIX WAS STUCK AND BROKE WHEN IT WAS PASSED THROUGH THE TRANSFER SUTURE LOOP AND WAS PULLED. THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PROCEDURE WAS RESUMED, WITH A 10 MINUTE DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647164 ↗
• MalfunctionJun 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN TIGHTENING, ONE (1) Q-FIX KNOTLESS ALL-SUTURE ANCHOR CAME OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN AN ADDITIONAL HOLE. THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25616976 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A Q-FIX ANCHOR WAS DEPLOYED AND WHEN SHUTTLING, THE SUTURE BROKE EARLY AND SHORT. THE WRONG END WAS PULLED THROUGH THE PASSAGE OF TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369096 ↗
• MalfunctionMay 27, 2026Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A HIP LABRAL REPAIR, THE Q-FIX ANCHOR HAD AN ISSUE ON DEPLOYMENT WHERE THE STITCHES GOT STUCK IN THE ANCHOR INSERTER AND APPEARED TO HAVE A KNOT IN THE SHUTTLE DITCH. AFTER FAILING TO REDUCE THE SUTURE, THE IMPLANT WAS EXPLANTED USING THE DRILL AND SHAVER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310851 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A HIP LABRAL REPAIR, AFTER A Q-FIX REPAIR STITCH WAS PLACED THROUGH LABRUM AND ATTEMPTED TO SHUTTLE THE STITCH THROUGH ANCHOR BODY; THE SHUTTLE STITCH CAME OUT AND THE REPAIR STITCH HAD A 1 INCH TAIL COMING OUT OF THE ANCHOR BODY. IT WAS TRIED TO BE RETRIEVED AND REDUCED USING A GRASPER, BUT IT DID NOT BUDGE. AFTER FAILING TO REDUCE THE SUTURE, THE IMPLANTS WAS EXPLANTED USING THE DRILL AND SHAVER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310838 ↗
• MalfunctionMay 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A BANKART REPAIR, THE Q-FIX ANCHOR DID NOT DEPLOY, SUTURE BALL DID NOT FORM, AND SHEATHS DID NOT FUNCTION PROPERLY. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25137425 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TAPE BROKE WHEN THE Q-FIX ANCHOR WAS IMPLANTED, AND THE INSERTER WAS REMOVED FROM THE BONE HOLE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083549 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING A BONE BLOCK SURGERY, WHILE SHUTTLING, THE SHUTTLE SUTURE OF ONE (1) Q-FIX KNOTLESS ANCHOR GOT BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919824 ↗
• MalfunctionApr 18, 2026Failure to Advance

  IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION PROCEDURE, THE LAST Q-FIX KNOTLESS ANCHOR DID NOT FULLY REDUCE THE LABRAL AND GOT STUCK. THE SELF LOCKING MECHANISM FAILED TO CONTINUE TO REDUCE THE SUTURE. THE DOCTOR HAD TO CUT THE SUTURE AT THE ANCHOR POINT. NO FLOATING SUTURE MATERIAL WAS LEFT INSIDE THE PATIENT OTHER THAN THE ANCHOR WITHIN THE BONE THAT HAD BEEN DEPLOYED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24919823 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A BANKART REPAIR SURGERY, AFTER ONE (1) Q-FIX SUTURE ANCHOR WAS IMPLANTED, WHEN THE TAPE WAS PASSED THROUGH THE LABRUM, IT SLIPPED OUT OF THE LOOP AND COULD NOT BE SUTURED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A 15 MINUTE DELAY. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744447 ↗
• MalfunctionMar 30, 2026Failure to Cycle

  IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, THE RECONSTRUCTION MINI-TAPE FROM TWO (2) Q-FIX ANCHORS COULD NOT BE FULLY TIGHTENED. THE ANCHORS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A MITEK HEALIX COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24723279 ↗
• MalfunctionMar 22, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER DEPLOYING THE Q-FIX SUTURE ANCHOR, THE SURGEON REMOVED THE IMPLANT HOLDER AND REALIZED THAT THE SHUTTLING SUTURE HAD BEEN SPLIT INTO TWO SEPARATE LIMBS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN A NEW BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24658892 ↗
• MalfunctionMar 14, 2026Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) Q-FIX ANCHORS BROKE AND PULLED OUT OF THE BONE WHEN THE SURGEON WAS PULLING DOWN THE REPAIR SUTURE. THE CORRECT DRILL AND DRILL GUIDE WAS PROVIDED AND THE CORRECT ANCHOR DEPLOYMENT TECHNIQUE WAS APPLIED TO BOTH AFFECTED ANCHORS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

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

  MAUDE report 24600298 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT DURING A BICEPS TENDINOSIS, ONE QFIX KNOTLESS ANCHOR WAS SUCCESSFULLY IMPLANTED AND THE SURGEON WENT TO SEPARATE THE MINITAPE FROM THE PASSING SUTURE AND IT WAS NOTICED THE PASSING SUTURE WAS BROKEN IN ITS CONTINUITY, MAKING IT UNUSABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP ON AN ADDITIONAL BONE HOLE MADE WITH A 1.8 MM Q-FIX DRILL. THE DRILL HOLE WAS FILLED WITH THE SUTURE BALL OF THE QFIX. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24545729 ↗
• MalfunctionMar 4, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WITH BICEPS TENODESIS, THE SURGEON IMPLANTED THE QFIX KNOTLESS ANCHOR. WHEN ATTEMPTING TO SEPARATE THE MINI-TAPE FROM THE PASSING SUTURE, IT WAS NOTICED THAT THE PASSING SUTURE WAS IN TWO PIECES, RENDERING IT UNUSABLE. THE OUTER MATERIAL APPEARED FRAYED WHILE ONLY THE CORE REMAINED INTACT.THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP ON A NEW HOLE, THE DRILLED HOLE WAS FILLED WITH THE SUTURE BALL OF THE QFIX. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24507556 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY LABRAL REPAIR FEMORPLASTY, A Q-FIX KNOTLESS WAS DEPLOYED NORMALLY, THE REPAIR SUTURE WAS PASSED THROUGH THE LABRUM AND GOT READY TO SHUTTLE USING THE END OF THE SHUTTLE STITCH; BUT IT WAS NOTICED THAT THE SHUTTLE STITCH LOOP WAS NOT THERE AND HAD APPARENTLY DELAMINATED. THE SUTURE WAS FOUND ON THE FLOOR. THE ANCHOR WAS DRILLED OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID LEFT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455717 ↗
• MalfunctionFeb 21, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A MPFL OPEN SURGERY, A 1.8 MM STRAIGHT DRILL WAS USED TO PREPARE THE BONE FOR IMPLANTATION. ONE (1) Q-FIX 1.8 MM ANCHOR WAS THEN INSERTED INTO THE DRILL SLEEVE AND DEPLOYED NORMALLY. THE MINITAPE WAS THEN PLACED INTO THE COBRAID BLACK LOOP TO BE SHUTTLED ACROSS THE IMPLANT, AND THE END OF THE MINITAPE WAS VISIBLE EXITING THE IMPLANT. THE SURGEON CONTINUED TO TUG ON THE MINITAPE TAIL TO REDUCE THE LOOP, HOWEVER, THE TAIL SNAPPED MIDWAY, AND UPON REMOVAL OF THE TAPE, THE PART THAT WAS SUPPOSED TO ENTER THE IMPLANT COULD BE SEEN TO BE CRUMBLED, CAUSING IT TO BE TOO THICK TO BE SHUTTLED INTO THE IMPLANT. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH AN EQUIVALENT S+N BACK UP PRODUCT. THE SURGEON USED A 2.3MM BIORAPTOR PK WITH A 2.3 MM DRILL INTO A NEW HOLE, AND THE REMAINING Q-FIX 1.8 ANCHOR IS STILL IN PATIENT'S BONE, THE MINITAPE EXCESS WAS CUT. NO PATIENT INFORMATION AVAILABLE. NO VOID LEFT. NO PATIENT HARM OR INJURY. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24410355 ↗
• MalfunctionFeb 7, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING AN LET PROCEDURE, TTHE Q-FIX ANCHOR SHUTTLE SUTURE WAS PULLED THROUGH THE ANCHOR AS SOON AS THE ANCHOR WAS DEPLOYED AND WAS UNABLE TO PASS THE REPAIR SUTURE THROUGH THE INTERNAL MECHANISM OF THE ANCHOR. THE SURGEON CREATED A SECOND BONE HOLE TO USE AN ADDITIONAL ANCHOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24285986 ↗
• MalfunctionFeb 5, 2026Material Deformation

  IT WAS REPORTED THAT, DURING A LABRUM PROCEDURE, A Q-FIX ANCHOR TRANSFER LOOP WAS FRAYED AND NOT PRESENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A PUSHLOCK COMPETITOR DEVICE USING THE Q-FIX REPAIR SUTURE AND ANOTHER MINITAPE IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24273250 ↗
• MalfunctionDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR, THE Q-FIX 1.8MM ANCHOR WAS PULLED OUT OF THE BONE WHEN TENSIONING THE KNOT. THE ANCHOR WAS REMOVED FROM INSIDE THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT INSERTED INTO AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23917750 ↗
• MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ACL RECONSTRUCTION AND LATERAL EXTRA-ARTICULAR TENODESIS, AFTER PREPARING THE INSERTION SITE WITH A 1.8 MM Q-FIX DRILL KIT, THE SURGEON PULLED THREE SUTURES TOGETHER AFTER TWO (2) Q-FIX KNOTLESS ANCHORS WERE DEPLOYED, AND THE ANCHORS WERE STILL INSIDE THE DRILL HOLE. HOWEVER, WHEN SHORTENING THE BLUE MINITAPE TO SECURE THE TENDON, THE WHOLE ANCHORS WERE OUT FROM THE FEMUR DRILL HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. NO VOID WAS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Perforation

  MAUDE report 23863687 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, A Q-FIX KNOTLESS ANCHOR'S LOOP MECHANISM USED TO LOAD THE TAPE INTO THE ANCHOR BROKE. 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 23827073 ↗
• MalfunctionDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A REVISION PCL + MCL REPAIR, TWO STAPLES FROM ANOTHER COMPANY WERE USED FOR PRIMARY FIXATION .THE Q-FIX ANCHOR WAS THEN DEPLOYED AND THE TISSUE WAS REPAIRED USING THE REPAIR SUTURE, THE ANCHOR WAS PULLED OUT, AFTER THE BLACK AND WHITE SUTURE WAS PULLED OUT OF THE ANCHOR AND DISCARDED, THE REPAIR SUTURE WAS PULLED FOR TENSION WHICH WAS WHEN THE ANCHOR CAME OUT. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE, THE DOCTOR ENDED UP JUST USING THE STAPLES TO COMPLETE THE REPAIR AS THE KNOTLESS Q FIX WAS JUST GOING TO BE USED AS AN ADDITIONAL SUPPORT. THERE WAS A SMALL HOLE LEFT WHERE THE QFIX PULLED OUT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WERE GILLIES, FORCEPS, NIBBLERS. THE PATIENT IS WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23703824 ↗
• MalfunctionNov 17, 2025Failure to Cycle; Physical Resistance/Sticking; Failure to Cycle; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY AND LABRAL REPAIR THE SURGEON DEPLOYED THE Q-FIX KNOTLESS ANCHOR, PASSED THE SUTURE AROUND THE LABRUM, AND SHUTTLED THE REPAIR SUTURE THROUGH THE ANCHOR PER STANDARD PROCEDURE WITHOUT INCIDENT; HOWEVER, WHEN TENSIONING THE REPAIR SUTURE, IT BECAME STUCK IN THE SELF-LOCKING MECHANISM BEFORE FULL TENSION WAS ACHIEVED, PREVENTING PROPER LABRAL REPAIR. THE REPAIR SUTURES OF THE FAILED ANCHOR WERE REMOVED, A NEW HOLE WAS DRILLED AS THE ANCHOR REMAINED FIXED IN THE ACETABULUM, AND A NEW Q-FIX KNOTLESS SUTURE ANCHOR WAS SUCCESSFULLY IMPLANTED, LEAVING THE PREVIOUS SUTURE BALLS IN THE PATIENT. THE INSERTION SITE WAS PREPARED USING THE Q-FIX ALL-SUTURE ANCHOR TWIST DRILL WITH THE Q-FIX ALL-SUTURE ANCHOR DRILL GUIDE XL, CROWN TIP, 1.8MM, IN A ROUTINE MANNER WITH DRILL CYCLING. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP, AND THE STATUS OF THE PATIENT IS WELL, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23566891 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, WHEN SHUTTLING THE Q-FIX SUTURE DOWN TO TENSION, THE SHUTTLING SUTURE CAME OUT OF THE ANCHOR AND DID NOT PASS THE REPAIR SUTURE. SURGERY WAS COMPLETED USING A COMPETITOR DEVICE INSTEAD, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901292 ↗