Q-FIX 72290123Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00885556662618), received between Aug 27, 2020 and Jun 7, 2026 — classified as 20 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2026Break

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER ARTHROSCOPY, THE BALL OF THE Q-FIX HAD BROKEN OFF FROM THE REMAINING SUTURE. ALL THE PIECES WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP, THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE, NO VOIDS WERE LEFT IN THE PATIENT. 1.8 Q FIX SLEEVE AND DRILL WERE USED TO PREPARE THE INSERTION SITE AND THE SITE WAS CLEARED OF ALL DEBRIS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422624 ↗
• MalfunctionApr 13, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS PROCEDURE, THE Q-FIX SUTURE DETACHED FROM THE ANCHOR AFTER THE DEPLOYMENT KNOB WAS TURNED AND THE SUTURE SPOOL WAS UNWOUND. TWO PIECES OF SUTURE WITH FRAYED ENDS WERE REMOVED FROM THE PROXIMAL END OF THE INSERTER. THE SUTURE ANCHOR WAS NOT VISIBLE, AND IT IS UNCLEAR WHETHER THE ANCHOR REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24860655 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT, DURING A PERONEUS TENDON DISLOCATION REPAIR PROCEDURE, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN THREE (3) Q-FIX MINI SUTURE ANCHORS WERE IMPLANTED AND THE INSERTER REMOVED FROM THE BONE HOLE, THE ONLY SUTURE CAME OUT FROM THE BONE HOLE AND WAS BROKEN. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818109 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING AN ELBOW UCL REPAIR, ON THE DEPLOYMENT OF ONE (1) Q-FIX MINI INTO THE ULNA, THE SUTURE SNAPPED. IT WAS SEVERED BY THE INNER SHEATH OF THE ANCHOR INSERTER. THE SURGEON DRILLED OUT THE SUTURE ANCHORS AND DEPLOYED ANOTHER ONE SUCCESSFULLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINAL BONE HOLE. THE PATIENT'S STATUS IS REPAIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742349 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER LABRAL REPAIR, ON THE DEPLOYMENT OF ONE (1) Q FIX MINI ANCHOR INTO THE GLENOID, THE SUTURE SNAPPED. IT WAS SEVERED BY THE INNER SHEATH OF THE ANCHOR INSERTER. THE SURGEON DRILLED OUT THE SUTURE ANCHOR, THE REMNANTS OF THE DRILLED-OUT SUTURE ANCHOR WERE REMOVED WITH AN ARTHROSCOPIC GRABBER. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP IN THE ORIGINAL BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT'S STATUS IS REPAIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742174 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER LABRAL REPAIR, ON THE DEPLOYMENT OF ONE (1) Q FIX MINI ANCHOR INTO THE GLENOID, THE SUTURE SNAPPED. IT WAS SEVERED BY THE INNER SHEATH OF THE ANCHOR INSERTER. THE SURGEON DRILLED OUT THE SUTURE ANCHOR, THE REMNANTS OF THE DRILLED-OUT SUTURE ANCHOR WERE REMOVED WITH AN ARTHROSCOPIC GRABBER. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP IN THE ORIGINAL BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT'S STATUS IS REPAIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742130 ↗
• MalfunctionMar 30, 2026Break

  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 MINI SUTURE 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 24714164 ↗
• MalfunctionMar 2, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, AFTER THE INSERTION SITE WAS PREPARED WITH A 1.8 MM DRILL AND CLEARED OF ALL DEBRIS, A Q-FIX MINI ANCHOR FAILED TO DEPLOY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE CLOSE TO THE ORIGINAL HOLE. THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24489911 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT, DURING A MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION, A Q-FIX MINI SUTURE ANCHOR WAS DEPLOYED INTO THE MEDIAL BORDER OF THE PATELLA USING THE TECHNIQUE AS PER IFU. AS THE DEPLOYED ANCHOR WAS REMOVED FROM THE DRILL GUIDE, THERE WERE NO SUTURES COMING OUT OF THE BONE HOLE; IT APPEARED THAT THE SUTURES MAY HAVE BEEN AMPUTATED FROM THE ALL-SUTURE ANCHOR DEEP TO THE BONE SURFACE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24465682 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY- LABRAL REPAIR PROCEDURE, (3) 1.8 MM Q-FIX MINI SUTURE ANCHOR FAILED STRAIGHT OUT OF THE BOX AS THE SLIDING MAGNUM WIRE WAS ALREADY SNAPPED AND PULLED OUT OF THE BODY OF THE ANCHOR. ADDITIONAL BONE HOLES HAD TO BE DRILLED DUE TO THE FAILURE. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT, LEAVING A VOID IN THE PATIENT. PATIENT IS FINE, ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24454857 ↗
• MalfunctionFeb 21, 2026Break

  IT WAS REPORTED THAT, DURING AN OPEN ATFL PROCEDURE, AFTER A QFIX 1.8 MINI SUTURE ANCHOR WAS DEPLOYED AND THE INSERTER WAS REMOVED FROM THE BONE HOLE, THE SUTURE WAS BROKEN. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS. 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 24410364 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT, DURING AN MPFL RECONSTRUCTION, AFTER DEPLOYMENT ONE (1) Q-FIX MINI SUTURE ANCHOR WAS PULLED OUT FROM THE PROXIMAL END OF THE INSERTER IN 2 HALVES, AS THOUGH THE RADIALLY EXPANDED ANCHOR HAD BEEN AMPUTATED FROM THE 2 SUTURE TAILS. ANOTHER ANCHOR WAS DEPLOYED IN A DIFFERENT HOLE. IT'S UNCLEAR WHETHER THE ANCHOR WAS STILL IN THE INITIAL BONE HOLE OR NOT. 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 problems: Perforation

  MAUDE report 24345492 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY AND LABRAL REPAIR, THE MAGNUM WIRE OF ONE (1) Q-FIX SNAPPED AFTER DEPLOYMENT AS THE HANDLE WAS TAKEN OFF, IT WAS MANAGED TO SLIDE THE REMAINING SUTURE THROUGH THE ANCHOR TO USE. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208620 ↗
• MalfunctionJan 9, 2026Break; Component Missing

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN TWISTING THE HANDLES, A Q-FIX MINI SUTURE ANCHOR WAS DEPLOYED SUCCESSFULLY, THEN THE SUTURE CAME OFF AND WAS BROKEN. IT WAS FOUND THAT THE SUTURE ANCHOR WAS NOT INITIALLY FILLED INSIDE THE SHAFT. THE PROCEDURE WAS RESUMED, AFTER A 15-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022102 ↗
• MalfunctionDec 29, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN ACHILLES TENDON REPAIR, THREE (3) QFIX FAILED TO BE DEPLOYED CORRECTLY INTO THE BODY. WHEN TURNING THE KNOB ON THE BACK UNTIL THE HARD STOP, THE SUTURES CAME ALL THE WAY OUT THROUGH THE INSERTER. NO BALL WAS CREATED AND NOTHING STAYED IN THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE IN THE SAME BONE HOLE AND ADDITIONAL HOLES. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23917152 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A LATERAL EXTRAARTICULAR TENODESIS, TWO (2) Q-FIX SUTURE ANCHORS IMMEDIATELY SNAPPED. THE SUTURE BALL AT THE DISTAL END OF THE ANCHOR HAD DEPLOYED AND REMAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP IN A NEW ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767086 ↗
• MalfunctionNov 24, 2025Failure to Fire; Physical Resistance/Sticking; Failure to Fire; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LATARJET PROCEDURE, TWO (2) Q-FIX MINI SUTURE ANCHORS DID NOT DEPLOY AND WERE STUCK INSIDE THE INSERTER; UPON REMOVAL OF THE INSERTER, THEY CAME OUT. DURING DRILLING, IT SOUNDED LIKE A SCREW WAS HIT. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES. A NEW HOLE WAS DRILLED, AND THE 3RD ANCHOR WAS DEPLOYED NORMALLY. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23638243 ↗
• MalfunctionNov 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, TWO (2) Q-FIX 1.8 MINI ANCHORS DID NOT DEPLOY AND WERE PULLED OUT WHEN THE DRILL GUIDE WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP INTO AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23569571 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN ARFL RECONSTRUCTION PROCEDURE, THE SUTURE OF THE 1.8 Q FIX ANCHOR BROKE WHILE THE SUTURE WAS BEING LIGATED. 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 23392435 ↗
• MalfunctionOct 20, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER THE Q-FIX MINI SUTURE ANCHOR WAS SUCCESSFULLY DEPLOYED AND THE INSERTER WAS REMOVED FROM THE BONE HOLE, IT WAS NOTICED THAT THE SUTURE CAME OFF AND 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 23336148 ↗
• MalfunctionOct 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED DURING A LEFT SHOULDER SOFT TISSUE REPAIR, THE SURGEON USED 1.8MM Q-FIX MINI. AFTER PREPPING BONE WITH 1.8MM QFIX MINI DRILL AND SLEEVE, THE IMPLANT WAS INSERT INTO THE SLEEVE AFTER BEING CLEARED OF ALL DEBRIS . THE IMPLANT HANDLE WAS TURNED CLOCKWISE TO A HARD STOP, UNFORTUNATELY THE IMPLANTED FAILED TO DEPLOY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT ON AN ADDITIONAL BONE HOLE ,A VOID WAS LEFT IN PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23222085 ↗
• MalfunctionSep 23, 2025Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL + LATERAL EXTRA ARTICULAR TENODESIS IT WAS NOTED THAT WHEN DEPLOYING THE Q- FIX ANCHOR, THE SUTURE TURRET DID NOT REDUCE BACK DOWN TO THE HANDPIECE AS USUAL. WHEN THE SUTURE LIMBS WERE REMOVED FROM THE DEVICE, THE ENTIRE SUTURE CAME OUT. IT WAS NOTED WHEN THE SUTURE WAS HANDED OFF THE TABLE THAT IT SOMEHOW TORN WHEN THE DEPLOYMENT HAD TAKEN PLACE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL BONE HOLE. THERE WAS A VOID LEFT. THE INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A STANDARD 1.8 QFIX MINI DISPOSABLE DRILL KIT. THE DRILL BIT WAS CYCLED IN AND OUT TO ENSURE BONE DEBRIS WERE CLEARED BEFORE ANCHOR INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23126883 ↗
• MalfunctionSep 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER THE INSERTION SITE WAS PREPARED USING A 1.8 MM MINI DRILL KIT AND CLEARED OF ALL DEBRIS, THE Q-FIX ANCHOR WAS DEPLOYED AS STANDARD. UPON UNRAVELLING THE SUTURE FROM THE END OF THE DEVICE, IT CAME STRAIGHT THROUGH, WHILE THE ANCHOR REMAINED IMPLANTED. THE SUTURE APPEARED TO BE SNAPPED IN HALF. THE REPORTED ANCHOR WAS LEFT SECURED WITHIN THE PATIENT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE, USED IN AN ADDITIONAL BONE HOLE. 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 23108491 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QFIX 1.8 MINI SUTURE WAS CUT OR DETACHED FROM THE ANCHOR WHEN REMOVING THE ANCHOR AND GUIDE AFTER DEPLOYMENT. THE ANCHOR WAS LEFT IN THE PATIENT¿S BONE BUT WITHOUT SUTURE TO WORK WITH. SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD, PLACED IN AN ADDITIONAL DRILLED BONE HOLE. A SMALL VOID, A 1.8 DRILLED HOLE, WAS LEFT IN THE PATIENT. 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 22802224 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS AND CYCLED MULTIPLE TIMES WITH A DRILL, THE Q-FIX SUTURES SNAPPED INSIDE THE INSERTER WHEN THE SURGEON ATTEMPTED TO PULL IT OUT. THE ANCHOR REMAINED INSIDE THE PATIENT AND WAS NOT REMOVED, AND THE SUTURES WERE CUT. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE INSTEAD, USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS RECOVERING POST-SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22491659 ↗