Q-FIX 25-1800Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00885556724606), received between May 19, 2020 and Jun 8, 2026 — classified as 38 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Break” (52 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 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE Q-FIX ANCHOR DID NOT FORM A SPHERE AFTER IT WAS INSERTED. THE ANCHOR WAS PULLED OUT. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. AN ADDITIONAL HOLE WAS REQUIRED FOR THE BACK UP DEVICE, THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25438468 ↗
• MalfunctionMay 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE A SURGERY, IT WAS NOTICED THAT THE PACKAGING OF A Q-FIX ALL SUTURE ANCHOR WAS OPEN. THE PROCEDURE WAS PERFORMED, 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 25230714 ↗
• MalfunctionMay 18, 2026Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR, AFTER ONE (1) Q-FIX ALL SUTURE ANCHOR WAS DEPLOYED. WHEN THE IMPLANT HANDLE AND THE CURVE DRILL GUIDE WERE REMOVED, 2 LIMBS OF SUTURE CAME OUT ALONG WITH THE DRILL GUIDE. NO BUNCHED UP BALL OF SUTURE SEEN. BOTH LIMBS OF SUTURE LOOKS LIKE IT WAS CUT. IMPLANT HANDLE WAS COMPLETE AND IN A DEPLOYED STATE, AND NOTHING WAS LEFT INSIDE THE HANDLE. IT IS UNKNOWN IF ALL THE PIECES WERE REMOVED FROM THE PATIENT. AN ADDITIONAL BONE HOLE WAS DRILLED TO PUT THE NEW IMPLANT AND THERE WAS A VOID LEFT IN THE PATIENT. 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: Perforation

  MAUDE report 25211773 ↗
• MalfunctionApr 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS NOTICED THAT THE Q-FIX SUTURES WERE UNWOUND FROM THE CLEAT AND WERE NOT SNAGGED BY THE CLEAT, WHILE THE ANCHOR INSERTER WAS REMOVED FROM THE GUIDE. THE GUIDE WAS REMOVED AND THE SUTURE STRANDS DID NOT APPEAR TO BE ATTACHED TO THE ANCHOR AS STRANDS EASILY CAME OUT IN THEIR ENTIRETY, AS IF CUT BY THE INSERTER. THE ANCHOR BODY WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACKUP DEVICE LEAVING NO VOID IN THE PATIENT. PATIENT IS RECOVERING WELL, NORMAL EXPECTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24921390 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY, ONE 1.8MM Q-FIX BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912866 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING SHOULDER GLENOID LABRUM REPAIR SURGERY, THE CONNECTION POINT BETWEEN THE SPHERE AND THE SUTURE OF A 1.8MM Q-FIX ALL SUTURE ANCHOR BROKE, AND THE SUTURE FAILED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750401 ↗
• MalfunctionMar 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, TWO (2) Q-FIX ALL SUTURE ANCHOR CAME OUT FROM BONE AFTER DEPLOYMENT. THE PROCEDURE WAS RESUMED, WITH A GREATER THAN 30 MIN DELAY, USING A SIMILAR S+N BACKUP PRODUCT. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638396 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT, DURING A BICEP TENODESIS, A Q-FIX ANCHOR APPEARED TO DEPLOY AS NORMAL, BUT WHEN THE DEPLOYMENT HANDLE WAS REMOVED, THE SUTURE PULLED OUT AS WELL AND APPEARED TO BE CUT IN TWO PIECES. THE ANCHOR WAS LEFT IN PLACE. THE PROCEDURE WAS RESUMED, AFTER A 5-MIN 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 24605327 ↗
• MalfunctionMar 14, 2026Break

  IT WAS REPORTED THAT, DURING A BANKART REPAIR PROCEDURE, AFTER DEPLOYING A Q-FIX ANCHOR AND PULLING THE INSERTER OUT, WHEN TYING THE KNOT, THE SUTURE BROKE AFTER THROWING THE FIRST SQUARE KNOT. A CRAB CLAW WAS USED TO UNWOUND THE SUTURE AND ENOUGH LENGTH WAS SALVAGED TO TIE THE SAME LIMB. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600302 ↗
• MalfunctionMar 9, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, ONE (1) Q-FIX SUTURE ANCHOR DID NOT DEPLOY PROPERLY. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. 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 24547595 ↗
• MalfunctionMar 9, 2026Failure to Fire; Material Deformation

  IT WAS REPORTED THAT, DURING A PROCEDURE, AFTER INSERTION, THE SHAFT OF A Q-FIX ALL SUTURE ANCHOR WAS FOUND TO BE BENT, AND THE ANCHOR COULD NOT BE ACTIVATED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION, YET THE DURATION OF THE DELAY IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543799 ↗
• MalfunctionMar 7, 2026Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE Q-FIX WAS INSERTED INTO THE BONE HOLE AND THE HANDLE WAS TWISTED, ONLY THE SUTURE CAME OUT FROM THE BONE HOLE, THE SUTURE DETACHED FROM THE Q-FIX. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541650 ↗
• MalfunctionMar 7, 2026Break

  IT WAS REPORTED THAT, DURING A HIP SCOPE, AFTER DEPLOYMENT OF ONE (1) Q-FIX ANCHOR THE SURGEON PULLED ON SUTURE TO CHECK FIXATION AND IT RIPPED OFF THE BODY OF THE ANCHOR. THE BODY OF THE ANCHOR WAS LEFT SECURED INSIDE THE PATIENT. AN ADDITIONAL BONE HOLE WAS REQUIRED. THERE WAS A VOID LEFT IN THE PATIENT. 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 WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 24541130 ↗
• MalfunctionMar 7, 2026Break

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, AFTER DEPLOYING A Q-FIX ANCHOR AND PULLING THE INSERTER OUT, THE SUTURES APPEARED TO HAVE BEEN CUT FROM THE DISTAL TIP OF THE INSERTER OR DYE. THE ANCHOR HAD TO BE 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 FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS RECOVERING WELL AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539941 ↗
• MalfunctionMar 7, 2026Failure to Advance; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE 1.8MM Q FIX ALL SUTURE ANCHOR DID NOT ANCHOR PROPERLY AND WAS PULLED UP UPON REMOVAL OF GUIDE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT ON AN ADDITIONAL BONE HOLE, LEAVING A VOID IN THE PATIENT. A 1.8MM Q-FIX DRILL BIT WAS USED TO PREPARE THE INSERTION SITE. PATIENT IS DOING WELL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24539924 ↗
• MalfunctionMar 7, 2026Failure to Fire

  IT WAS REPORTED THAT DURING HIP LABRAL REPAIR, WHEN THE INSERTER OF THE Q-FIX SUTURE ANCHOR WAS WITHDRAWN IT WAS EVIDENT THE ANCHOR HAD NOT DEPLOYED. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S&N BACK-UP DEVICE IN A NEW BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24539911 ↗
• MalfunctionMar 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC BANKHARTS REPAIR, THE Q-FIX SUTURE GOT CUT THROUGH AND TORN WHILE KNOTTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED BONE HOLE; NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A DRILL BIT 1.8MM Q-FIX, THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT WAS SAFE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539889 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION PROCEDURE, THE LIMBS OF TWO (2) 1.8 MM Q-FIX WERE BROKEN; AFTER THE FIRST ANCHOR WAS DEPLOYED, ONE LIMB OF THE SUTURE BROKE WHEN MINIMAL FORCE WAS APPLIED, EVEN THOUGH NO KNOTS HAD BEEN TIED. AFTER DEPLOYING THE SECOND ANCHOR, A HALF-LOOP WAS THROWN, AND WHILE TYING IT DOWN AND TESTING THE FIXATION OF THE ANCHOR, THE LIMB AGAIN BROKE MID SUBSTANCE. THE ANCHOR WAS LEFT SECURED IN PATIENT. THE PROCEDURE WAS THEN RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP ON ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24526954 ↗
• MalfunctionMar 5, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A PROCEDURE, A Q-FIX WAS NOT DEPLOYING CORRECTLY. WHEN THE ANCHOR WAS COMPLETELY TWISTED, THE SUTURE GOT CUT BY THE INSERTER, LEAVING THE ANCHOR IN THE DRILLED HOLE WITH THE SUTURES FALLING RIGHT OUT WHEN REMOVING THE GUIDE AND ANCHOR. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OF IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519927 ↗
• MalfunctionMar 5, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE Q-FIX WAS NOT DEPLOYING CORRECTLY. WHEN THE ANCHOR WAS COMPLETELY TWISTED, THE SUTURE GOT CUT BY THE INSERTER, LEAVING THE ANCHOR IN THE DRILLED HOLE WITH THE SUTURES FALLING RIGHT OUT WHEN REMOVING THE GUIDE AND ANCHOR. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OF IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515351 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A PROCEDURE, ONE (1) Q-FIX WAS NOT DEPLOYING CORRECTLY. WHEN THE ANCHOR WAS COMPLETELY TWISTED, THE SUTURE GOT CUT BY THE INSERTER, LEAVING THE ANCHOR IN THE DRILLED HOLE WITH THE SUTURES FALLING RIGHT OUT WHEN REMOVING THE GUIDE AND ANCHOR. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OF IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476746 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY SURGERY, THE THREADS OF ONE (1) Q-FIX ALL SUTURE ANCHOR BROKE DURING KNOTTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414616 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS DRILLED USING A 1.8 MM Q-FIX DRILL AND GUIDE, AND CLEARED OF ALL DEBRIS, A Q-FIX ALL SUTURE ANCHOR WAS DEPLOYED AS USUAL USING THE TWISTING MECHANISM. THE SUTURES WERE UNWOUND FROM THE CLEAT AND WERE NOT SNAGGED BY THE CLEAT WHILE THE ANCHOR INSERTER WAS REMOVED FROM THE GUIDE. THE GUIDE WAS REMOVED AND THE SUTURE STRANDS DID NOT APPEAR TO BE ATTACHED TO THE ANCHOR. THE STRANDS EASILY CAME OUT IN THEIR ENTIRETY. UPON INSPECTION OF THE SUTURES, THERE WAS A DISTINCT TEAR IN THE SUTURE. THE ANCHOR BODY WAS LEFT IN THE HUMERUS. THE PROCEDURE WAS RESUMED, AFTER A 5 TO 10 MINUTES DELAY, USING A SIMILAR S+N BACK-UP. THE DOCTOR ELECTED TO UPSIZE THE DRILL TUNNEL WITH A 2.8 MM Q-FIX DRILL AND GUIDE. A 2.8 MM Q-FIX WAS DEPLOYED INTO THE TUNNEL WITHOUT ISSUES AND REPAIR OF THE SUBSCAPULARIS WAS PERFORMED WITHOUT FURTHER ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS RECOVERING WELL, WITH A NORMAL EXPECTED POSTOPERATIVE RECOVERY. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24413215 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A REVISION MPFL RECONSTRUCTION PROCEDURE, IT WAS NOTICED THAT ONE (1) Q-FIX ANCHOR REMAINED IN-SITE AFTER IT WAS DEPLOYED, BUT THE LOADED MINITAPE SUTURE TAILS WERE SEVERED IN HALF ONCE INSERTER AND GUIDE WERE REMOVED. THE SUTURES WERE REMOVED FROM PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT ON AN ADDITIONAL DRILLED BONE HOLE, LEAVING A VOID IN THE PATIENT. PATIENT IS HEALTHY HOWEVER IT WAS REPORTED THAT PRESENTED INSTABILITY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Joint Laxity; Perforation

  MAUDE report 24392890 ↗
• MalfunctionFeb 19, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SURGERY, WHEN TWISTING THE HANDLE, THE ANCHOR OF ONE (1) Q-FIX ANCHOR DID NOT DEPLOY AND THE SUTURE COMPLETELY CAME OFF FROM THE INSERTER. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390167 ↗