Q-FIX 72205882Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556901687), received between Aug 8, 2025 and May 3, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT, DURING AN ACL REPAIR, A Q-FIX KNOTLESS ANCHOR WAS DEPLOYED IN THE RECOMMENDED MANNER WITH A 1.8MM DISPOSABLE KIT. WHEN THE DRILL GUIDE AND INSERTION DEVICE WERE REMOVED, THE BLUE REPAIR SUTURE WAS FED INTO THE LOOP OF THE COBRAID TRANSFER SUTURE AS PER TECHNIQUE; HOWEVER, AS THE SURGEON BEGAN TO PULL ON THE TRANSFER STITCH TO ADVANCE THE BLUE REPAIR SUTURE, THE TRANSFER STITCH BEGAN TO FRAY AND 'BALL UP' AT THE ANCHOR SITE. THE ENTIRE OUTER SHEATH OF THE TRANSFER STITCH SEPARATED FROM THE INNER CORE. THE SURGEON WAS UNABLE TO PULL THE TRANSFER STITCH LOOP WITH THE BLUE REPAIR SUTURE THROUGH THE Q-FIX ANCHOR. AFTER SEVERAL ATTEMPTS THE ANCHOR LOST FIXATION AND PULLED OUT OF THE FEMORAL BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONAL BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS DOING WELL, TWO WEEKS INTO REHABILITATION. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: Perforation

  MAUDE report 25063721 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT, DURING AN ABR PROCEDURE, AFTER THE Q-FIX ANCHOR WAS IMPLANTED, WHEN THE TRANSFER SUTURE WAS MANIPULATED, THE WHITE-BLACK SUTURE SNAPPED, TANGLED AND MAKING IT IMPOSSIBLE TO PULL IT THROUGH IN THE KNOTLESS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES USING A COMPETITOR DEVICE IN AN ADDITIONAL BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25061991 ↗
• MalfunctionApr 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER THE Q-FIX ANCHOR WAS DEPLOYED ACCORDING TO THE SURGICAL TECHNIQUE, THE MECHANISM FAILED AND THE REPAIR SUTURE NEVER MADE IT THROUGH THE CHINESE FINGER MECHANISM WHEN SHUTTLE THE REPAIR SUTURE, RENDERING IT UNUSABLE. THE PROCEDURE WAS AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON A NEW DRILLED BONE HOLE, LEAVING A VOID BUT STILL FILLED WITH THE SUTURE BALL OF THE ANCHOR THAT FAILED. THE PATIENT IS RECOVERING WELL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25029825 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, DURING THE KNOT TYING, THE SUTURE OF THE Q-FIX RUPTURED. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957370 ↗
• MalfunctionApr 17, 2026Detachment of Device or Device Component; Extra Components

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, WHEN TAKING OUT OF THE BOX A Q-FIX IT WAS NOTICED THAT THE IMPLANT HAD SOME EXCESS SUTURE STICKING OUT OF THE INSERTER TIP. UPON DEPLOYMENT, THE SUTURES APPEARED TO BE CUT FROM THE IMPLANT WHILE THE ANCHOR BODY STAYED. BOTH THE REPAIR AND SHUTTLE STITCH WERE CUT. ANOTHER ANCHOR WAS DRILLED IN THE SAME HOLE AND PLACED WITHOUT ERROR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918708 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN A Q-FIX KNOTLESS ANCHOR WAS IMPLANTED AND THE INSERTER REMOVED FROM THE BONE HOLE, ONLY ONE STRAND OF THE WHITE-BLACK SUTURE CAME OUT, THE SUTURE BROKE INSIDE THE PATIENT. 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 24904042 ↗
• MalfunctionMar 19, 2026Break; Material Frayed

  IT WAS REPORTED THAT DURING SURGERY, WHEN TWISTING THE HANDLE AND THE SHAFT WAS REMOVED FROM THE BONE HOLE, THE ONLY SUTURE OF ONE (1) Q-FIX ANCHOR CAME OUT FROM THE BONE HOLE AND IT WAS BROKEN. 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 24644139 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT THE BLACK PASSING SUTURE OF TWO (2) Q-FIX DEVICES BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519237 ↗
• MalfunctionMar 3, 2026Failure to Cycle

  IT WAS REPORTED THAT DURING AN ABR PROCEDURE, AFTER IMPLANTATION OF ONE (1) Q-FIX ANCHOR, THE SUTURE ATTACHED TO THE Q-FIX DID NOT SHRINK. IT WAS INSERTED AT THE 9 O'CLOCK POINT BEHIND THE ABR, AND THE CHINESE FINGER TRAP MECHANISM APPEARED UNDER THE ARTHROSCOPE WHEN THE REPAIR SUTURE WAS PASSED THROUGH WITH THE GUIDE SUTURE. THE SUTURE ANCHOR COULD NOT BE REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, AFTER A 6-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONAL DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24496035 ↗
• MalfunctionFeb 11, 2026Break; Failure to Advance; Extra Components

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, A Q-FIX KNOTLESS HAD A SHORT ADDITIONAL WHITE STITCH COMING OUT OF THE ANCHOR. IT HAD THE REPAIR STITCH, THE TWO LIMBS OF THE SHUTTLE STITCH, AND AN ADDITIONAL SINGLE WHITE LIMB COMING OUT OF THE ANCHOR. THE WHITE STITCH WAS PULLED OUT, BUT ONCE THE REPAIR STITCH WAS CONVERTED, IT WAS NOT POSSIBLE TO REDUCE THE LOOP AT ALL. THE TAIL OF THE REPAIR STITCH THEN BROKE, AND THE ANCHOR COULD NOT BE USED. THE ANCHOR SUTURE WAS CUT AND REMAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 20-MIN SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLES; NO VOIDS WERE LEFT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312371 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, WHEN A Q-FIX KNOTLESS ANCHOR WAS IMPLANTED AND UPON TAKING THE INSERTER OUT, IT WAS NOTICED THAT THE SHUTTLE STITCH WAS ALREADY BROKEN; THEREFORE, THE ANCHOR COULD NOT BE USED. THE ANCHOR´S SUTURE WAS CUT, AND THE ANCHOR REMAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 20-MIN SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLES, NO VOIDS WERE LEFT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304163 ↗
• MalfunctionJan 20, 2026Material Deformation

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, CLUMPING OCCURRED ON THE SUTURE OF A 1.8MM Q-FIX KNOTLESS ANCHOR AFTER IMPLANTATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A HELIX BR 4.5MM COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118824 ↗
• MalfunctionDec 16, 2025Component Missing; Material Deformation; Component Missing; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TRANSITION STITCH OF THE 1.8 MM Q-FIX APPEARED FRAYED AT THE BONE ANCHOR INTERFACE. WHEN IT WAS SHUTTLED, THE STITCH HAD NO LOOP. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR WHETHER ANY SURGICAL DELAY OCCURRED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820187 ↗
• MalfunctionDec 15, 2025Component Missing; Material Deformation; Component Missing; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TRANSITION STITCH OF THE 1.8 MM Q-FIX APPEARED FRAYED AT THE BONE ANCHOR INTERFACE. WHEN IT WAS SHUTTLED, THE STITCH HAD NO LOOP. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804024 ↗
• MalfunctionDec 12, 2025Component Missing; Material Deformation; Component Missing; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TRANSITION STITCH OF TWO (2) 1.8 MM Q-FIX APPEARED FRAYED AT THE BONE ANCHOR INTERFACE. WHEN THE STITCHES WERE SHUTTLED, THEY HAD NO LOOPS. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791861 ↗
• MalfunctionNov 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS NOTICED THAT THE Q-FIX KNOTLESS ANCHOR'S SHUTTLING PROCESS OF THE REPAIR SUTURE, FAILED. THE PROCEDURE WAS RESUMED AFTER A 15 MINUTE DELAY, USING A SIMILAR S+N BACK UP PRODUCT, USING THE ORIGINAL DRILLED BONE HOLE BY DRILLING OVER IT, LEAVING NO VOID IN THE PATIENT. PATIENT IS HEALTHY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23669335 ↗
• MalfunctionNov 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS NOTICED THAT THE Q-FIX KNOTLESS ANCHOR PULLED OUT THE HOLE AFTER REDUCING THE REPAIR SUTURE TO ACHIEVE TENSION TO THE TENDON. THE PROCEDURE WAS RESUMED AFTER A 15 MINUTE DELAY, USING A SIMILAR S+N BACK UP PRODUCT OF 2.8MM, USING THE ORIGINAL DRILLED BONE HOLE BY DRILLING OVER IT, LEAVING NO VOID IN THE PATIENT. PATIENT IS HEALTHY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23659806 ↗
• MalfunctionOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A Q-FIX KNOTLESS ANCHOR 1.8MM PULLED OUT, IT HAD NOT BEEN ACTIVELY DEPLOYED AND PULLED RIGHT OUT OF THE PILOT HOLE. THE PROCEDURE WAS RESUMED, AFTER A 2-MINUTE, USING THE SAME DEVICE BY ADJUSTING THE BONE HOLE LOCATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23306295 ↗
• MalfunctionOct 10, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT TWO (2) UNITS OF THE Q-FIX KNTLS ASA 1.8MM W/1 UB SUT BL (B)(4) LOT: 2173625 & (B)(4) LOT: 2178008) DIDN¿T BALL UP AGAINST THE INSERTER AND APPEARED TO BE CYLINDRICAL. IT TOOK AN ADDITIONAL MINUTE OR TWO AND HAD TO SLIGHTLY ALTER ANCHOR LOCATION WITH A SMALL DEFECT LEFT BEHIND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23271299 ↗
• MalfunctionAug 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SHOULDER LABRUM REPAIR, THE QFIX 1.8 KNOTLESS SUTURE ANCHOR DID NOT DEPLOY EVEN IF THE SUTURES WERE OUT ON THE OTHER END OF THE SHAFT. RESULTING TO A FAILED IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE ON AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22752199 ↗