Q-FIX 72205691Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556885635), received between Oct 24, 2024 and Jun 18, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN MPFL PROCEDURE, THE NEEDLE OF ONE (1) Q-FIX ANCHOR FELL OFF THE SUTURE, ONTO THE PATIENT. THE NEEDLE WAS REMOVED WITH AN ARTERY FORCEPS AND RELOADED IT INTO THE SUTURE. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED DUE TO THE PROLONGED SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553292 ↗
• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN MPFL PROCEDURE, THE NEEDLE OF ONE (1) Q-FIX ANCHOR FELL OFF THE SUTURE, ONTO THE PATIENT. THE NEEDLE WAS REMOVED WITH AN ARTERY FORCEPS AND RELOADED IT INTO THE SUTURE. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED DUE TO THE PROLONGED SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553288 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT, DURING A BROSTROM REPAIR, AFTER ONE (1) Q-FIX WITH NEEDLES SUTURE ANCHOR WAS DEPLOYED, WHILE TYING THE KNOT, THE KNOTS # 0 BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THE BACK-UP ANCHOR WAS DRILLED OVER WITH BIGGER DRILL BIT OF RESCUE ANCHOR. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25310938 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING SURGERY, THE DISTAL END OF THE DEPLOYMENT SYSTEM OF ONE (1) Q-FIX ANCHOR WAS BROKEN WHILE DEPLOYING THE IMPLANT. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036941 ↗
• MalfunctionApr 24, 2026Break; Material Deformation

  IT WAS REPORTED THAT, DURING A LEFT ANKLE ARTHROSCOPY, THE Q-FIX ANCHOR WAS IMPLANTED AND DEPLOYED AFTER BONE TUNNEL PREP WITH Q-FIX WITH NEEDLE DRILL AS PER SURGICAL TECHNIQUE. AFTER UNRAVELLING THE SUTURES AND REMOVING THE Q-FIX INSERTED IT WAS FOUND THAT THE METAL OUTER SHEATH FROM THE DISTAL TIP OF THE INSERTER HAD BROKEN OFF AND EMBEDDED IN THE BONE. A BIGGER SKIN INCISION WAS MADE TO ALLOW BETTER VISUAL FOR THE REMOVAL OF THE FOREIGN BODIES FROM THE PATIENT, ALL PIECES OF FOREIGN BODIES WERE REMOVED AND WERE CONFIRMED FLUOROSCOPICALLY. SOME BONE WAS REMOVED FROM THE TUNNEL ENTRANCE WHILE ATTEMPTING TO REMOVE THE BROKE METAL TIP OF THE INSERTER, WHILE DOING SO IT HAD DILATED THE TUNNEL AND THE IMPLANT PIECE WAS PULLED OUT WITH A TUG ON THE SUTURES. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 5 MINUTES USING A BACKUP TWINFIX ULTRA INTO THE ORIGINAL DRILL HOLE. NO VOIDS WERE LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24988815 ↗
• MalfunctionMar 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LATERAL LIGAMENT REPAIR, A Q-FIX NEEDLE WAS POPPING OFF THE # 0 SUTURE WITH LITTLE TO NO EFFORT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542226 ↗
• MalfunctionMar 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LATERAL LIGAMENT REPAIR, ONE (1) Q-FIX FAILED. TWO (2) Q-FIX NEEDLES WERE POPPING OFF THE #0 SUTURE WITH LITTLE TO NO EFFORT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541242 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LATERAL LIGAMENT REPAIR, Q-FIX NEEDLES WERE POPPING OFF THE #0 SUTURE WITH LITTLE TO NO EFFORT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523783 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LATERAL LIGAMENT REPAIR, THE NEEDLES OF TWO A Q-FIX DEVICES WERE POPPING OFF THE #0 SUTURE WITH LITTLE TO NO EFFORT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520901 ↗
• MalfunctionDec 29, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANKLE-INSTABILITY LATERAL LIGAMENT REPAIR, TWO OF THE NEEDLES ON THE Q-FIX WITH NEEDLES ANCHOR FELL OFF THE SUTURES WHILE THE SURGEON WAS SUTURING. IT APPEARED THAT THE NEEDLES HAD NOT BEEN PROPERLY FUSED/CRIMPED ONTO THE SUTURES TO BEGIN WITH. FURTHERMORE, THE SUTURE BROKE DURING KNOT TYING. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915365 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT, DURING A FOOT AND ANKLE SURGERY, THE ANCHOR OF ONE (1) Q-FIX WITH NEEDLES BROKE WHILE BEING DEPLOYED. 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 23887880 ↗
• MalfunctionSep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ANKLE LATERAL LIGAMENT REPAIR, THE Q-FIX WITH NEEDLES SUTURE WAS DEPLOYED, BUT AFTER INSERTION IT WAS PULLED OUT OF THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USED IN ANOTHER BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23075427 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DISTAL PORTION OF THE Q-FIX INSERTER BROKE OFF INSIDE THE PATIENT WHEN THE ANCHOR WAS BEING DEPLOYED. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PART WAS REMOVED WITH NO COMPONENT LEFT INSIDE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE. NO VOIDS WERE LEFT IN THE PATIENT. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181675 ↗
• MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SURGERY, ONE NEEDLE OF TWO (2) Q-FIX WITH NEEDLES ANCHORS FROM THE SAME BATCH CAME OFF THE SUTURES, ON THE FIRST PASS THROUGH THE TISSUE, ONE NEEDLE PER ANCHOR. THE NEEDLES WERE SUCCESSFULLY REMOVED FROM THE PATIENT, SINCE THEY CAME LOOSE WHILE STILL ATTACHED TO THE NEEDLE HOLDER, THEN IT WAS SIMPLY REMOVED. SURGERY WAS COMPLETED WITH A STERILE MAYO NEEDLE, INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526873 ↗