Q-FIX 25-2800Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00885556724644), received between Jul 17, 2020 and Jun 14, 2026 — classified as 25 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE SUTURE OF ONE (1) Q-FIX ALL SUTURE ANCHOR BROKE AT THE JUNCTION BETWEEN THE SUTURE BUNDLE AND THE SUTURE. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT 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 25496868 ↗
• MalfunctionMay 5, 2026Difficult to Insert; Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER LABRAL REPAIR, THE INSERTION SITE WAS PREPARED WITH A 2.8 MM DRILL BIT AND CLEARED OF ALL DEBRIS; HOWEVER, A Q-FIX ALL SUTURE ANCHOR WAS DIFFICULT TO INSERT INTO THE GUIDE BUT WAS EVENTUALLY SEATED WITH SLIGHT MALLETING. UPON DEPLOYMENT, THE ANCHOR WAS NOT RELEASING PROPERLY FROM THE INSERTER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. THERE WAS NOT A VOID LEFT IN THE PATIENT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25084412 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED USING A 2.8 MM BONE PUNCH AND CLEARED OF ALL DEBRIS, WHEN PULLING THE SUTURE OF A Q-FIX ALL SUTURE ANCHOR, THE SUTURE BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: Perforation

  MAUDE report 24896104 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, AFTER DEPLOYMENT OF TWO (2) Q-FIX ALL SUTURE ANCHORS THE SUTURE BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886089 ↗
• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, AFTER THE DEPLOYMENT OF THE Q-FIX ANCHOR, WHEN THE ROD WAS WITHDRAWN, IT WAS DISCOVERED THAT THE SUTURE HAD BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED HOLE; NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24786756 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE SUTURE OF (2) TWO Q-FIX ANCHORS BROKE WHEN THEY WERE DEPLOYED. THE SUTURE WAS REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS NO VOID LEFT IN THE PATIENT. THE INSERTION SITE WAS CLEARED OF AL DEBRIS PRIOR TO THE INSERTION. PATIENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723813 ↗
• MalfunctionMar 26, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY. A Q-FIX ANCHOR DID NOT OPEN. EVERYTHING WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN ARTHREX COMPETITOR DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION.

  Patient problems: Perforation

  MAUDE report 24701609 ↗
• MalfunctionMar 17, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE Q-FIX SUTURE ANCHOR HAD A PULL OUT FAILURE. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. AN ADDITIONAL BONE HOLE WAS REQUIRED, HOWEVER IT WAS REPORTED THAT THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT STATUS IS FINE.

  Patient problems: Perforation

  MAUDE report 24619713 ↗
• MalfunctionMar 2, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, AFTER THE INSERTION SITE WAS PREPARED USING A 2.8 MM Q-FIX DRILL KIT AND CLEARED OF ALL DEBRIS, A Q-FIX ANCHOR COULD NOT BE DEPLOYED AFTER INSERTING TO THE PILOT HOLE, USING A DISPOSABLE SHOULDER Q-FIX KIT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24484582 ↗
• MalfunctionFeb 27, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, AFTER THE INSERTION SITE WAS PREPARED USING A 2.8 MM Q-FIX DRILL KIT AND CLEARED OF ALL DEBRIS, A Q-FIX ALL SUTURE ANCHOR FAILED TO DEPLOY WHEN INSERTED INTO THE PILOT HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24477309 ↗
• MalfunctionFeb 27, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, AFTER THE INSERTION SITE WAS PREPARED USING A 2.8 MM Q-FIX DRILL KIT AND CLEARED OF ALL DEBRIS, TWO (2) Q-FIX ALL SUTURE ANCHORS COULD NOT BE DEPLOYED AFTER INSERTING INTO THE PILOT HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24477194 ↗
• MalfunctionFeb 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, A 2.8MM Q-FIX ALL SUTURE ANCHOR WAS PULLED OUT AFTER INSERTION. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP USED IN ANOTHER DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24473591 ↗
• MalfunctionFeb 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, TWO (2) UNITS OF A 2.8MM Q-FIX ANCHOR WERE PULLED OUT FROM THE BONE HOLE. THE ANCHOR WAS REMOVED BY THE INSERTER ITSELF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT, A TWINFIX OF 5.0 MM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24463223 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS NOTICED THAT AFTER EXITING THE NEEDLE BAR THE Q-FIX SUTURE BROKE. THE SUTURE WAS DETACHED, AND THEN THE SURGEON MADE A KNOT. IT WAS NOT RETRIEVED FORM THE PATIENT. THE BACK UP WAS USED IN AN ADDITIONAL HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24455916 ↗
• MalfunctionFeb 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A REDUCTION OPERATION OF ULNA FRACTURE, ONE Q-FIX COULDN'T BE DEPLOYED DURING NORMAL USE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE AN ADDITIONAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24322171 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, WHEN PULLING OUT THE WHITE-BLACK SUTURE OF TWO (2) Q-FIX ANCHORS, BROKE SUCCESSIVELY. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 24271842 ↗
• MalfunctionJan 21, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, ONE (1) Q-FIX SUTURE ANCHOR FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S+N BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24132656 ↗
• MalfunctionJan 19, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, TWO (2) Q-FIX SUTURE ANCHOR FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S+N BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24112130 ↗
• MalfunctionJan 15, 2026Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, AFTER PREPARING THE INSERTION SITE WITH A 2.9 MM DRILL AND CLEARING IT OF ALL DEBRIS, IT WAS NOTICED THAT THE Q-FIX ANCHOR'S BULGE DID NOT EXPAND IN THE BONE AND CAME OUT WITHOUT BEING DEPLOYED. THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT SMITH AND NEPHEW BACK UP DEVICE, USED IN AN ADDITIONALLY DRILLED BONE HOLE. THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS HEALTHY AND THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: Perforation

  MAUDE report 24079420 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE SUTURE OF A 2.8MM Q-FIX ALL SUTURE ANCHOR DIDN¿T DEPLOY FROM THE ANCHOR. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THEN IT WAS NOT POSSIBLE TO USE THE SAME HOLE BECAUSE WHILE PULLING THE Q-FIX ANCHOR OUT IT CREATES A BIGGER HOLE. SO, THEY TOOK A HEALICOIL ANCHOR INSTEAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THE CURRENT STATUS OF THE PATIENT IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23729870 ↗
• MalfunctionDec 1, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A FOOT ANKLE PROCEDURE, THE 1.8MM Q-FIX ANCHOR FAILED TO DEPLOY, AND THE HANDLE WAS SLIPPED. THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE USED IN AN ADDITIONAL DRILLED BONE HOLE, A VOID WAS LEFT IN THE PATIENT, AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23687471 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, ONE (1) 2.8MM Q-FIX ALL SUTURE ANCHOR WAS PLACED, THE KNOB WAS ROTATED CLOCKWISE, IT WAS EVIDENT HOW THE EXTERNAL SUTURES WERE DEPLOYED BUT DID NOT FORM THE KNOT, LEAVING THEM COMPLETELY EXPOSED. WHEN REMOVING THE INSERTER, IT WAS NOTICED THAT THE SUTURES WERE STILL INSIDE THE IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IMPLANT. AN ADDITIONAL HOLE WAS DRILLED TO USE THE BACK-UP IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23543368 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER LABRAL REPAIR PROCEDURE, THREE (3) QFIX 2.8 MM ANCHORS WERE IMPLANTED, AND THE SUTURES WERE PASSED THROUGH THE LABRUM WITHOUT DIFFICULTY. AN SMC KNOT WAS THROWN ON THE SUTURE AND SNUGGED DOWN USING A BRAND-NEW KNOT PUSHER. DURING TENSIONING, THE SUTURE SNAPPED WHEN PULLED AGAINST THE KNOT PUSHER WITH FORCE. EACH ANCHOR HAD TWO SUTURES PASSED AND TIED. THREE OF THE SUTURES SNAPPED DURING REDUCTION OF THE KNOT STACK AND WHILE THROWING HALF HITCHES OVER THE SMC STACK. THE SURGEON CONTINUED THE PROCEDURE USING THE SAME DEVICES AND REDUCED THE AMOUNT OF TENSION APPLIED TO REDUCE THE KNOTS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23532757 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A RIGHT SHOULDER ARTHROSCOPY + ROTATOR CUFF REPAIR SURGERY, THE Q-FIX ALL SUTURE ANCHOR GUIDE ROD WAS INSERTED THROUGH THE SKIN INCISION INTO THE LOWER EDGE OF THE RIGHT ROTATOR CUFF. A 2.8MM DRILL WAS INSERTED FOR POSITIONING. THE DRILL WAS REMOVED AND REPLACED WITH A 2.8MM Q-FIX ANCHOR WRENCH DRILL TO CREATE A BONE CHANNEL. A 2.8MM Q-FIX ANCHOR WAS INSERTED THROUGH THE BONE DRILLING GUIDE AND INTO THE BONE CHANNEL. IT WAS ROTATED CLOCKWISE, AND THE PROXIMAL ACTIVATION KNOB WAS INSERTED AND ROTATED UNTIL THE FIRST CLICK WAS HEARD. AFTER THAT, THE ROTATION CONTINUED UNTIL THE SECOND CLICK WAS NOT HEARD. THE SUTURE WAS LOOSENED FROM THE TAIL-END SUTURE KNOT, AND THE SUTURE WAS REMOVED. THE INSERTION DEVICE AND THE BONE DRILLING GUIDE WERE REMOVED. THE Q-FIX INSERTION DEVICE WAS TAKEN OUT, AND IT WAS FOUND THAT THE SUTURE WAS ALSO REMOVED ALONG WITH IT, AND IT WAS NOT STUCK IN THE BONE CHANNEL. THE PROCEDURE WAS RESUMED USING A COMPETITOR DEVICE FROM JOHNSON & JOHNSON IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460454 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, WHILE DEPLOYING TWO (2) 2.8 MM Q-FIX ANCHORS ACCORDING TO THE STANDARD AND OFFICIAL SURGICAL TECHNIQUE, THE SURGEON WAS IN THE FINAL STAGES OF TENSIONING TO REACH THE LIMITING TORQUE WHEN BOTH SUTURES OF THE DEVICES FAILED AND SNAPPED AT THE BASE OF THE ANCHOR SHAFTS, LEAVING SHORT TAILS THAT COULD NOT BE UTILIZED, THE SUTURES WERE BY MANUALLY RUNNING THEM OUT OF THE ANCHOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP ON THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460090 ↗