Q-FIX 72205883Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556901694), received between Feb 14, 2025 and May 27, 2026 — classified as 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING AN ABR PROCEDURE, WHEN THE LEADING SUTURE OF THE QFIX ANCHOR WAS PULLED, THE SUTURE GOT STUCK AND BROKEN. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT USING AN ADDITIONAL BONE HOLE, LEAVING A VOID IN THE PATIENT. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25310862 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUTURE OF THE Q-FIX ANCHOR BROKE DURING IMPLANTATION. 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 25211577 ↗
• MalfunctionApr 27, 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 25010454 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT, DURING AN ABR PROCEDURE, WHEN THE SHAFT WAS INSERTED INTO THE BONE HOLE AND ONE (1) Q-FIX KNOTLESS ANCHOR WAS DEPLOYED, A PRE-FORMED KNOT WAS OBSERVED SITUATED TOWARD THE CAUDAL END OF THE SLIT IN THE BLUE-WHITE SUTURE; HOWEVER, UPON PROCEEDING WITH THE RELAY MANEUVER, BOTH THE BLUE-WHITE SUTURE AND THE LEADING SUTURE SEVERED. THE BLUE-WHITE SUTURE OF THE IMPLANTED ANCHOR WAS THEN GRASPED WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE, THE SUTURE WAS COMPLETED IN THE LABRUM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859386 ↗
• MalfunctionMar 19, 2026Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER SUCCESSFULLY DEPLOYING THE 1.8 MM Q FIX ANCHOR, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO DISENGAGE THE SUTURE FROM THE INSERTER MECHANISM. MULTIPLE RELEASE ATTEMPTS WERE MADE; HOWEVER, THE SUTURE REMAINED ENGAGED WITHIN THE INSERTER ASSEMBLY. SIGNIFICANT TRACTION WAS APPLIED TO FREE THE SUTURE, BUT IT REMAINED ENTRAPPED AND COULD NOT BE RELEASED. THE MECHANISM WAS THEN MECHANICALLY PRIED OPEN TO RELEASE THE SUTURE, WHICH RESULTED IN THE FRACTURE OF THE METALLIC CONNECTING COMPONENT OF THE HOLDER EXTERNAL TO THE PATIENT. DESPITE THIS, THE SUTURE REMAINED RETAINED WITHIN THE IMPLANT HOLDER. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A CHANGE IN SURGICAL TECHNIQUE BY CUTTING THE SUTURE TO RELEASE IT AND PROCEEDING WITH A CONVENTIONAL KNOT-TYING METHOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643915 ↗
• MalfunctionMar 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE 1.8MM Q-FIX ANCHOR DID NOT FIX INTO THE BONE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480014 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT, DURING A ABR PROCEDURE, THE BLACK-WHITE SUTURE OF ONE (1) Q-FIX BROKE WHEN IT WAS BEING PULLED UP AT THE MOMENT THE SUTURES WERE BEING PASSED THROUGH THE LABRUM, PREVENTING FURTHER PULLING. AS A RESULT, THE WHITE-BLUE SUTURE REMAINED IN A LOOP SHAPE INSIDE THE JOINT. THE WHITE-BLUE SUTURE WAS CUT AND REMOVED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PATIENT BONE QUALITY IS HARD, THE PROCEDURE WAS RESUMED, AFTER A 5 MINUTE 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 24429673 ↗
• MalfunctionJan 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A BANKART SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN PASSING TO THE LABRUM, THE SUTURE OF A Q-FIX KNOTLESS ANCHOR WAS TEAR AFTER IMPLANTATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE, AS THE ANCHOR WAS ALREADY FIXATED AND SECURED WHEN THE ISSUE WAS NOTICED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109363 ↗
• MalfunctionNov 20, 2025Failure to Cycle; Physical Resistance/Sticking; Failure to Cycle; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION THE SURGEON SUCCESSFULLY DEPLOYED THE 1.8MM Q-FIX KNOTLESS ANCHOR. THE REPAIR SUTURE WAS SUCCESSFULLY PASSED AROUND LABRUM AND SHUTTLED THROUGH THE ALL-SUTURE ANCHOR PER-STANDARD PROCEDURE. WHEN TENSIONING THE REPAIR SUTURE AROUND THE LABRUM, THE REPAIR SUTURE BECAME STUCK, AND THE SURGEON WAS UNABLE TO FULLY REDUCE THE SUTURES PREVENTING A PROPER LABRAL REPAIR. A NEW HOLE WAS DRILLED AS THE ANCHOR REMAINED FIXED IN THE GLENOID. THE SURGEON ELECTED TO CUT REPAIR SUTURE OF THE Q-FIX KNOTLESS DEVICE, LEAVING JUST THE ANCHOR. HE THEN DRILLED AND IMPLANTED A 1.8MM Q-FIX IN CLOSE PROXIMITY TO THE Q-FIX KNOTLESS ANCHOR. THERE WAS NO VOID, THE IMPLANTED SUTURE BALL WAS LEFT IN THE PATIENT. THE INSTRUMENTS TO PREPARE THE INSERTION SITE WERE Q-FIX ALL-SUTURE ANCHOR TWIST DRILL, 1.8MM, IN CONJUNCTION WITH Q-FIX ALL-SUTURE ANCHOR DRILL GUIDE XL, CROWN TIP, 1.8MM, NONSTERILE, REUSABLE STERILE, DISPOSABLE. INSERTION SITE WAS PREPARED IN A ROUTINE MANNER; THE DRILL WAS CYCLED. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE CUR

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23613341 ↗
• MalfunctionNov 15, 2025Failure to Cycle; Physical Resistance/Sticking; Failure to Cycle; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION THE SURGEON SUCCESSFULLY DEPLOYED THE 1.8MM Q-FIX KNOTLESS ANCHOR. THE REPAIR SUTURE WAS SUCCESSFULLY PASSED AROUND LABRUM AND SHUTTLED THROUGH THE ALL-SUTURE ANCHOR PER-STANDARD PROCEDURE. WHEN TENSIONING THE REPAIR SUTURE AROUND THE LABRUM, THE REPAIR SUTURE BECAME STUCK, AND THE SURGEON WAS UNABLE TO FULLY REDUCE THE SUTURES PREVENTING A PROPER LABRAL REPAIR. A NEW HOLE WAS DRILLED AS THE ANCHOR REMAINED FIXED IN THE GLENOID. THE SURGEON ELECTED TO CUT REPAIR SUTURE OF THE Q-FIX KNOTLESS DEVICE, LEAVING JUST THE ANCHOR. HE THEN DRILLED AND IMPLANTED A 1.8MM Q-FIX IN CLOSE PROXIMITY TO THE Q-FIX KNOTLESS ANCHOR. THERE WAS NO VOID, THE IMPLANTED SUTURE BALL WAS LEFT IN THE PATIENT. THE INSTRUMENTS TO PREPARE THE INSERTION SITE WERE Q-FIX ALL-SUTURE ANCHOR TWIST DRILL, 1.8MM, IN CONJUNCTION WITH Q-FIX ALL-SUTURE ANCHOR DRILL GUIDE XL, CROWN TIP, 1.8MM, NONSTERILE, REUSABLE STERILE, DISPOSABLE. INSERTION SITE WAS PREPARED IN A ROUTINE MANNER; THE DRILL WAS CYCLED. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE CUR

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23564252 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, IT WAS NOTICED THAT A Q-FIX TRANSFER SUTURE TORE AND RIPPED AS IT WAS PASSING THROUGH THE EYELET. THE ANCHOR WAS LEFT SECURE INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 5-MIN DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONAL BONE HOLE. A VOID WAS LEFT IN THE PATIENT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23347775 ↗
• MalfunctionFeb 14, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY PROCEDURE, WHILE TWO (2) Q-FIX KNOTLESS ANCHORS WERE BEING USED, IT WAS NOTICED THAT THE BLACK MARKS ON THE DISTAL END OF THE COBRAID BLUE REPAIR STITCH WERE MORE PROXIMAL THAN NORMAL, WITH THE LAST BLACK LINE ENDING AT THE 9 INCHES DOWN THE REPAIR STITCH VS. THE STANDARD 4 INCHES. FOR THE FIRST Q-FIX KNOTLESS ANCHOR (B)(4), THE COBRAID BLUE REPAIR STITCH WAS BEING LOADED AT THE LAST BLACK MARK WHICH ENDED UP BEING RIGHT WHERE THE SIZE 2-0 TO #2 JUNCTION WAS OF THE REPAIR STITCH. WHILE THE REPAIR STITCH WAS BEING SHUTTLED THROUGH THE ANCHOR USING THE BLACK AND WHITE TRANSFER STITCH, THE EXCESS FRICTION OF THE #2 END OF THE REPAIR SUTURE CAUSED THE TRANSFER STITCH TO BREAK DURING SHUTTLING. THE REPAIR STITCH HAD ALREADY BEEN SHUTTLED THROUGH THE ANCHOR, SO THE SURGEON WAS ABLE TO GRAB THE REPAIR STICH LIMB WITH A GRASPER DOWN THE CLEAR-TRAC CANNULA AND COMPLETE PROPER TENSIONING. FOR THE SECOND Q-FIX KNOTLESS ANCHOR (B)(4), THE SURGEON IGNORED THE BLACK LINES AND LOADED THE REPAIR STITCH AT THE 4-INCH POINT ON THE DISTAL END OF THE REPAIR STITCH. THE ANCHOR PREFORMED FINE. A DIFFERENT LOT (2168841) WAS USED AFTER REALIZING THAT TWO ANCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21389111 ↗