Q-FIXRecalls & reported problems across all models
Smith & Nephew, Inc. · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 478
- Deaths reported
- 0
- Injuries reported
- 114
- Recalls
- 0
We found 21 models of Q-FIX by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 478 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2018 and Jun 27, 2026 — classified as 114 injuries, 364 malfunctions.
The most frequently reported specific device problem is “Break” (198 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Q-FIX problems
Device problems
- Break198
- Device Dislodged or Dislocated80
- Failure to Fire70
- Detachment of Device or Device Component39
- Material Deformation23
- Material Split, Cut or Torn23
- Adverse Event Without Identified Device or Use Problem18
- Inaccurate Information14
Patient problems
- No Clinical Signs, Symptoms or Conditions236
- Perforation176
- Device Embedded In Tissue or Plaque60
- Pain12
- Rupture10
- Foreign Body In Patient9
- Unspecified Tissue Injury7
- No Information6
Q-FIX models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Q-FIX 25-1800Fastener, fixation, nondegradable, soft tissue129 reports
- Q-FIX 25-2800Fastener, fixation, nondegradable, soft tissue114 reports
- Q-FIX 72290123Fastener, fixation, nondegradable, soft tissue75 reports
- Q-FIX 72205884Fastener, fixation, nondegradable, soft tissue30 reports
- Q-FIX 72205882Fastener, fixation, nondegradable, soft tissue20 reports
- Q-FIX 25-1810ORTHOPEDIC MANUAL SURGICAL INSTRUMENT14 reports
- Q-FIX 72205691Fastener, fixation, nondegradable, soft tissue14 reports
- Q-FIX 72205695Fastener, fixation, nondegradable, soft tissue13 reports
- Q-FIX 72205885Fastener, fixation, nondegradable, soft tissue13 reports
- Q-FIX 72290118BIT, DRILL12 reports
- Q-FIX 72205883Fastener, fixation, nondegradable, soft tissue12 reports
- Q-FIX 25-1811ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- Q-FIX 25-2810ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- Q-FIX 72290126ACCESSORIES,ARTHROSCOPIC5 reports
- Q-FIX 72205859Fastener, fixation, nondegradable, soft tissue5 reports
- Q-FIX 72205693Fastener, fixation, nondegradable, soft tissue5 reports
- Q-FIX 72290035Accessories, arthroscopic1 report
- Q-FIX 72290119BIT, DRILL1 report
- Q-FIX 72290120BIT, DRILL1 report
- Q-FIX 72205692Orthopedic manual surgical instrument1 report
- Q-FIX 72205694BIT, DRILL1 report
Recent Q-FIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2026Break; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, AFTER THE SUTURE ANCHOR WAS IMPLANTED, THE MINITAPE OF Q-FIX WAS STUCK AND BROKE WHEN IT WAS PASSED THROUGH THE TRANSFER SUTURE LOOP AND WAS PULLED. THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PROCEDURE WAS RESUMED, WITH A 10 MINUTE DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25647164 ↗MalfunctionJun 25, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN TIGHTENING, ONE (1) Q-FIX KNOTLESS ALL-SUTURE ANCHOR CAME OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN AN ADDITIONAL HOLE. THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 25616976 ↗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 ↗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 ↗InjuryJun 10, 2026Break
IT WAS REPORTED THAT, DURING A SURGERY, THE DISTAL TIP OF THE Q-FIX DRILL BROKE WHILE DRILLING IN THE GLENOID FOSSA AND WAS EMBEDDED IN THE BONE. BROKEN PIECE COULD NOT BE REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25465500 ↗MalfunctionJun 8, 2026Failure to Fire
IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE Q-FIX ANCHOR DID NOT FORM A SPHERE AFTER IT WAS INSERTED. THE ANCHOR WAS PULLED OUT. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. AN ADDITIONAL HOLE WAS REQUIRED FOR THE BACK UP DEVICE, THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 25438468 ↗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 ↗MalfunctionJun 2, 2026Break
IT WAS REPORTED THAT, DURING A PROCEDURE, A Q-FIX ANCHOR WAS DEPLOYED AND WHEN SHUTTLING, THE SUTURE BROKE EARLY AND SHORT. THE WRONG END WAS PULLED THROUGH THE PASSAGE OF TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25369096 ↗InjuryJun 2, 2026Break
IT WAS REPORTED THAT, DURING A SURGERY, THE DISTAL TIP OF A Q-FIX DRILL BROKE WHILE DRILLING IN THE GLENOID FOSSA AND WAS EMBEDDED IN THE BONE. BROKEN PIECE COULD NOT BE REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368894 ↗MalfunctionJun 1, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING AN ATFL SURGERY, THE Q-FIX ULTRA ANCHOR GOT PULLED OUT FROM THE BONE AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S&N BACK-UP DEVICE IN ANOTHER BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 25349147 ↗MalfunctionMay 28, 2026Failure to Fire
IT WAS REPORTED THAT DURING A POST TIB REPAIR WITH INTERNAL BRACING PROCEDURE, THE Q-FIX ULTRA COULDN'T BE DEPLOYED. USING A 1.25 MM DRILL PIN TO LOCATE AT THE TARGETED BONE, THEN A 2.9MM CANNULATED DRILL BIT WAS USED TO CREATE INITIAL HOLE WITH THE EXTREMITIES GUIDE. THE SURGEON PLACED THE Q-FIX ULTRA IN THE INITIAL HOLE AND STARTED TO DEPLOY BY TWISTING THE KNOB OF THE IMPLANT, TILL 2 POP SOUND WAS HEARD, BUT IMPLANT DIDN'T DEPLOY IN THE BONE AND IT FORMED THE BALL IN THE METAL SHEALTH INSTEAD, THEN THE SUTURE WAS RELEASED AND THE IMPLANT WAS REMOVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO ANCHOR WAS IMPLANTED, WHICH RESULTED IN A VOID LEFT IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 25326239 ↗MalfunctionMay 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, DURING A SURGERY, A Q-FIX KNOTLESS ANCHOR WAS DEPLOYED WITHOUT ANY COMPLICATION; HOWEVER, WHEN PULLING THE SUTURES OUT OF THE CLEAT AND THEN REMOVING THE ANCHOR, AS THE SUTURES WERE RUNNING DOWN THE CANNULATION OF THE INTRODUCER, THEY WERE CAUGHT. THE SURGEON THEN HAD TO PULL SLIGHTLY HARDER TO HAVE THEM EXIT THE INTRODUCER AND FOUND THE LOOPED PORTION OF THE BLACK AND WHITE PASSING SUTURE WAS SHREDDED. THE EXTERNAL SHEATH COMPONENT WAS TORN FROM THE INTERNAL PORTION OF THE LOOP LEAVING THE DEVICE WITHOUT A LOOP. ALSO, THE 2-0 SUTURE OF THE BLUE SUTURE HAD A PORTION TORN OFF. THE ANCHOR WAS LEFT INSIDE THE PATIENT, BUT THE SUTURES WERE REMOVED; NO VOID WAS LEFT IN THE PATIENT SINCE PART OF THE ¿REMPLISSAGE¿ WHERE THE POSTERIOR CAPSULE WAS PULLED INTO THE DEFECT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Perforation
MAUDE report 25311315 ↗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 ↗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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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