Q-FIX 72205695Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556885642), received between Jun 12, 2024 and Nov 30, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionNov 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A LATERAL COLLATERAL LIGAMENT KNEE RECONSTRUCTION, THE SURGEON DEPLOYED THE Q-FIX WITH NEEDLES AFTER COMPLETING APPROPRIATE BONE PREP USING THE Q-FIX NEEDLES DRILL AND UNIVERSAL EXTREMITIES GUIDE. AFTER THE SURGEON HAS USED NEEDLES TO SUTURE THE MINITAPE INTO THE HAMSTRING GRAFT, THE Q-FIX BALL OF SUTURE PULLS STRAIGHT OUT. NOTHING REMAINED IN THE PATIENT AS WE CUT THE ANCHOR AWAY FROM THE GRAFT POST AFTER IT WAS PULLED OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING A 2.8 MM Q-FIX; THEREFORE, THEY DRILLED OVER THE ORIGINAL DRILL HOLE WITH A 2.8 MM DRILL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677075 ↗
• InjuryNov 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, THE OUTER SHEATH OF THE METAL TIP OF A Q-FIX BROKE OFF INSIDE THE PATIENT'S BONE. THE PIECE REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23532473 ↗
• InjuryOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC INTERNAL BRACE CONSTRUCTION ANKLE PROCEDURE, AFTER THE Q-FIX ANCHOR WAS DEPLOYED AND WHEN REMOVING THE IMPLANT APPLICATOR HANDLE, A METAL PIECE BROKE OFF AND WAS LEFT INSIDE THE DRILLED TUNNEL. AN OPEN SURGERY WAS USED TO RETRIEVE THE METAL PIECE WITH TWEEZERS WHICH RESULTING IN CARTILAGE INJURIES. THERE WAS A SURGICAL DELAY OF MORE THAN 20 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cartilage damage

  MAUDE report 23279359 ↗
• MalfunctionSep 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LET ON THE KNEE, THE QFIX WITH NEEDLES WAS DEPLOYED BUT PULLED OUT OF THE BONE. THE ANCHOR WAS PULLED OUT SO NOTHING WAS LEFT INSIDE THE PATIENT. THERE WAS AN CHANGE IN THE SURGICAL TECHNIQUE AS THE SURGEON USED A STAPLE INSTEAD, LEAVING A VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23048091 ↗
• MalfunctionSep 9, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A BONE HOLE WAS DRILLED AS PER INSTRUCTIONS FOR USE. THE ANCHOR OF THE Q-FIX NEEDLE WOULD NOT INSERT DOWN THE HOLE INTO THE GUIDE. THE TIP ENDED UP SNAPPING, THERE WERE NO PIECES INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN A NEW BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23001418 ↗
• MalfunctionSep 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A BONE HOLE WAS DRILLED AS PER INSTRUCTIONS FOR USE. THE Q-FIX WOULD NOT ADVANCE INTO THE BONE HOLE AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN A NEW BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23001408 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE LATERAL LIGAMENT RECONSTRUCTION, THE TIP OF THE Q-FIX WITH NEEDLES AND MINITAPE BROKE OFF IN THE DRILL HOLE DURING IMPLANTATION AS THE ANGLE OF INSERTION ALTERED FROM THE DRILL TRAJECTORY JUST AS THE ORANGE SLEEVE TIP WAS GETTING CLOSE TO THE BONE. THE BROKEN TIP WAS REMOVED WITH NEEDLE HOLDERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINALLY DRILLED HOLE USING A THE 2.2MM DRILL FOR PREPARATION OF THE INSERTION SITE AND LEAVING NO VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900932 ↗
• MalfunctionJan 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A LATERAL ANKLE LIGAMENT REPAIR, THE INNER SHAFT OF THE Q-FIX GOT TRAPPED IN THE DRILL HOLE AFTER THE ANCHOR WAS REMOVED. A GRASPER WAS USED TO REMOVED THE INNER SHAFT FROM THE PATIENT. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY OF 3 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146375 ↗
• MalfunctionDec 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MPFL REPAIR ON PATELLA, AFTER REMOVING THE NEEDLE TAB AND PULLING THE INSERTER OUT, THE Q-FIX ANCHOR CAME OUT OF THE BONE WHEN THE SURGEON GAVE A LIGHT PULL BY HAND TO TEST IT AND NOTHING REMAINED IN THE WOUND. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH MAYO NEEDLES, NO VOIDS REMAINED IN THE PATIENT, A Q-FIX ULTRA DRILL WAS USED TO RE-DRILL THE BONE HOLE IN THE SAME LOCATION. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048801 ↗
• MalfunctionDec 23, 2024Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DELTOID LIGAMENT REPAIR, THE Q-FIX SUTURES WERE TOO SHORT. ALSO, AFTER PASSING THE NEEDLE THROUGH THE SOFT TISSUE AND THE SURGEON TRIED TO PULL THE SLACK OF THE MINITAPE SUTURE THROUGH, THE NEEDLE SEPARATED FROM THE MINITAPE SUTURE. A MAYO NEEDLE WAS USED TO PASS THE MINITAPE SUTURE AFTER THE NEEDLE CAME OFF. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE (REPAIR OF THE DELTOID LIGAMENT TO THE DISTAL INSERTION OF THE TENDONS). THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000185 ↗
• MalfunctionDec 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LATERAL LIGAMENT REPAIR PROCEDURE, THE NEEDLE OF THE Q-FIX MINITAPE CAME OFF THE SUTURE AFTER PASSING THE NEEDLE THROUGH THE SOFT TISSUE ON THE ANKLE AND WHEN IT WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875372 ↗
• InjuryJun 12, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THERE WAS AN ISSUE WITH A Q-FIX ANCHOR ON THE INFERIOR PATELLA. ONCE DRILLED AND CYCLED, IT WAS TRIED TO PUT ANCHOR DOWN GUIDE. INSERTER WAS NOT SLIDING INTO THE HOLE. IT WAS DRILLED AGAIN AND THE SURGEON WAS VERY CONSCIOUS OF THE TRAJECTORY INSERTING THE ANCHOR INTO THE HOLE. THE ANCHOR INSERTER FIT INTO THE HOLE BUT DID NOT APPEAR ALL THE WAY DOWN. ALTHOUGH IT DID NOT FEEL ALL THE WAY DOWN TO THE SURGEON, IT FELT ENOUGH TO DEPLOY. IT WAS DEPLOYED AND IT WORKED AND HELD. EXTRA DRILL HOLES WERE MADE IN PATELLA FROM HAVING TO RE-DRILL AND CYCLE MULTIPLE TIMES. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19520640 ↗
• InjuryJun 12, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE SURGERY ON THE SUPERIOR PATELLA, ONCE DRILLED AND CYCLED AND VERY CONSCIOUS OF THE TRAJECTORY, TWO (2) Q-FIX ANCHORS WERE BURNED. THE FIRST ONE DID NOT FIT AFTER MULTIPLE ATTEMPTS OF DRILLING AND ATTEMPTING DIFFERENT TRAJECTORIES. THE SURGEON FORCED AND THE INSERTER BENT. ANOTHER ANCHOR WAS TRIED AND DRILLED AGAIN, WITH THE SAME CAUTIOUS APPROACH TO START, AND YIELDED THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING A 1.8 Q-FIX WITH MINITAPE SMITH AND NEPHEW BACK UP DEVICE IN AN ADDITIONAL DRILLED BONE HOLE THAT WAS DONE FROM HAVING TO RE-DRILL AND CYCLE MULTIPLE TIMES. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19520628 ↗