Q-FIX 72205885Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556901717), received between Apr 2, 2025 and May 27, 2026 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A SURGERY, A Q-FIX KNOTLESS ANCHOR WAS DEPLOYED WITHOUT ANY COMPLICATION; HOWEVER, WHEN PULLING THE SUTURES OUT OF THE CLEAT AND THEN REMOVING THE ANCHOR, AS THE SUTURES WERE RUNNING DOWN THE CANNULATION OF THE INTRODUCER, THEY WERE CAUGHT. THE SURGEON THEN HAD TO PULL SLIGHTLY HARDER TO HAVE THEM EXIT THE INTRODUCER AND FOUND THE LOOPED PORTION OF THE BLACK AND WHITE PASSING SUTURE WAS SHREDDED. THE EXTERNAL SHEATH COMPONENT WAS TORN FROM THE INTERNAL PORTION OF THE LOOP LEAVING THE DEVICE WITHOUT A LOOP. ALSO, THE 2-0 SUTURE OF THE BLUE SUTURE HAD A PORTION TORN OFF. THE ANCHOR WAS LEFT INSIDE THE PATIENT, BUT THE SUTURES WERE REMOVED; NO VOID WAS LEFT IN THE PATIENT SINCE PART OF THE ¿REMPLISSAGE¿ WHERE THE POSTERIOR CAPSULE WAS PULLED INTO THE DEFECT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25311315 ↗
• MalfunctionMay 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, AFTER (2) Q-FIX SUTURE ANCHORS WOULD BE DEPLOYED AND THE MINITAPE PULLED, THE SUTURE ANCHORS CAME OFF. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL DRILLED HOLE, THERE WAS A VOID LEFT. THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25238035 ↗
• MalfunctionApr 30, 2026Break; Failure to Cycle

  IT WAS REPORTED THAT, DURING A BICEPS TENODESIS, A HOLE WAS DRILLED IN THE BICEPS GROOVE USING THE Q-FIX DRILL AND GUIDE AND THE INSERTION SITE CLEARED OF ALL DEBRIS. A Q-FIX KNOTLESS ANCHOR WAS PLACED DOWN THE GUIDE AND TWISTED TO ENGAGE THE SUTURE KNOT; HOWEVER, AFTER THE STANDARD TWISTING AND CRACKS ASSOCIATED WITH THE DEPLOYMENT, THE BALLING SUTURE MAY HAVE SNAPPED CAUSING THE BALL NOT TO FORM. THE IMPLANT WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25052251 ↗
• MalfunctionApr 19, 2026Failure to Cycle

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER IMPLANTATION, THE SUTURE OF ONE (1) Q-FIX ANCHOR COULD NOT BE KNOTTED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A 10 MINUTE DELAY. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. 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 24921374 ↗
• MalfunctionMar 17, 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. THE SURGEON ENDED UP REMOVING THE REMAINING LIMBS OF THE TRANSFER SUTURES FROM THE ANCHOR. THE REPAIR SUTURES WERE TIED TOGETHER AS PART OF THE BANKART REPAIR. THERE WERE NO VOIDS LEFT. 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 24617059 ↗
• MalfunctionMar 15, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER DEPLOYING ONE (1) Q-FIX KNOTLESS ANCHOR THE SURGEON CHECKED THE SHUTTLING SUTURE TO ENSURE IT MOVED SMOOTHLY. DURING THE CHECK, FRAYING WAS NOTED ON ONE LIMB OF THE SUTURE. WHEN ATTEMPTED TO PASS THE SHUTTLING SUTURE, IT BROKE BEFORE THE REPAIR SUTURE COULD BE LOADED. THE ORIGINAL ANCHOR REMAINS IN THE PATIENT'S BONE. THE SURGEON USED A DIFFERENT HOLE PLACEMENT FOR THE BACKUP DEVICE. NO VOID WAS LEFT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT STATUS IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24601483 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT, DURING SHOULDER STABILIZATION, A Q-FIX 1.8MM WAS DEPLOYED BUT WHEN THE INSERTER WAS REMOVED, THE SUTURES CAME OUT WITH IT AND THE ANCHOR STAYED BEHIND BELOW THE BONE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT, THE SURGEON DRILLED THROUGH THE ANCHOR OF THE ORIGINAL HOLE AND RE-USED THAT HOLE FOR THE BACKUP ANCHOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424993 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE, IT WAS NOTICED THAT THREE (3) Q FIX ANCHORS FAILED. THE FIRST Q FIX ANCHOR WAS SUCCESSFULLY DEPLOYED, BUT THE SUTURE BROKE AS IT APPEARED TO BE FRAYED WHEN SURGEON FLOSSED THE TRANSFER SUTURE (CASE (B)(4). THE SECOND Q-FIX ANCHOR COULD NOT BE DEPLOYED FROM THE INSERTER (CASE (B)(4) AND WHEN PLACING THE THIRD AND FINAL ANCHOR IT WAS DEPLOYED SUCCESSFULLY, BUT WHEN FLOSSING THE SUTURE, IT BROKE AGAIN (CASE (B)(4). THE REMAINING SUTURES WERE STRIPPED BY PULLING THEM AND THE REPAIR SUTURES WERE CUT WITH A SUTURE CUTTER. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLES, LEAVING NO VOID IN THE PATIENT. PATIENT OUTCOME IS NORMAL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322324 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE, IT WAS NOTICED THAT WHEN PLACING A Q FIX ANCHOR, IT WAS DEPLOYED SUCCESSFULLY, BUT WHEN FLOSSING THE SUTURE, IT BROKE. THE REMAINING SUTURE WAS STRIPPED BY PULLING AND THE REPAIR SUTURE WAS CUT WITH A SUTURE CUTTER. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT OUTCOME IS NORMAL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313651 ↗
• MalfunctionJan 5, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC LABRUM REPAIR, AFTER THE INSERTION SITE WAS PREPARED USING A Q-FIX 1.8 MM DRILL AND GUIDE AND CLEARED OF ALL DEBRIS, TWO (2) Q-FIX KNOTLESS ANCHORS FAILED TO DEPLOY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING TWO EQUIVALENT S+N BACK-UPS, ONE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE AND ANOTHER REQUIRED THE DRILLING OF AN ADDITIONAL BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME. THE PATIENT'S STATUS IS FINE.

  Patient problems: Perforation

  MAUDE report 23961058 ↗
• MalfunctionOct 28, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION PROCEDURE, IT WAS NOTICED THAT UPON DEPLOYING THE Q-FIX BALL IMPLANT, IT DID NOT DEPLOY. THE SUTURES WERE VISIBLE ON THE END OF THE HANDLE BUT THE SUTURE BALL IMPLANT DID NOT DEPLOY ON THE OTHER END. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL DRILLED HOLE, THERE WAS A VOID LEFT. THE INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A 1.8 Q FIX FLEXIBLE DRILL KIT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23404255 ↗
• MalfunctionJul 14, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ANTERIOR STABILIZATION, THE Q-FIX ANCHOR¿S MINITAPE WAS STUCK AND COULD NOT BE FULLY REDUCED AFTER INSERTION. THE SUTURE THEN BROKE WHEN ATTEMPTING TO REDUCE IT, AND THE ANCHOR REMAINED IN SITU. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL S+N BACKUP ANCHORS. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22491682 ↗
• MalfunctionApr 2, 2025Unstable; Unstable

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, AFTER THE 1.8 MM Q-FIX ANCHOR WAS IMPLANTED, IT DID NOT HOLD TENSION AS IT SHOULD HAVE. THE REPAIR SUTURE WAS EASILY SLICK BACK AND FORTH AT WILL WITH LITTLE FORCE ON THE REPAIR SUTURE. THE ANCHOR WAS LEFT SECURED EMBEDDED INTO THE PATIENTS BONE. IT WAS NECESSARY TO DRILL A BACKUP BONE HOLE TO INSERT AN ANCHOR CAPABLE OF MAINTAINING TENSION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP ANCHOR, AS IT WAS PUT DIRECTLY OVER THE OLD ANCHOR. THERE WAS A SURGICAL DELAY OF 10 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 21759275 ↗