ACUFEXRecalls & reported problems across all models
Smith & Nephew, Inc. · 86 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 314
- Deaths reported
- 0
- Injuries reported
- 115
- Recalls
- 0
We found 86 models of ACUFEX by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 314 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2017 and Jun 20, 2026 — classified as 115 injuries, 199 malfunctions.
The most frequently reported specific device problem is “Break” (192 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 ACUFEX problems
Device problems
- Break192
- Material Separation24
- Difficult to Open or Close17
- Flaked17
- Detachment of Device or Device Component10
- Failure to Align9
- Mechanical Jam9
- Insufficient Device Problem Information7
Patient problems
- No Clinical Signs, Symptoms or Conditions215
- No Known Impact Or Consequence To Patient50
- Foreign Body In Patient18
- No Information17
- No Patient Involvement11
- Injury5
- Device Embedded In Tissue or Plaque2
- Perforation2
ACUFEX models
86 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACUFEX 72204044BIT, SURGICAL25 reports
- ACUFEX 012013ACCESSORIES,ARTHROSCOPIC25 reports
- ACUFEX 72204042BIT, SURGICAL19 reports
- ACUFEX 72204046BIT, SURGICAL16 reports
- ACUFEX 72204045BIT, SURGICAL14 reports
- ACUFEX 012044ACCESSORIES,ARTHROSCOPIC13 reports
- ACUFEX 72204043BIT, SURGICAL11 reports
- ACUFEX 010001ACCESSORIES,ARTHROSCOPIC11 reports
- ACUFEX 012014ACCESSORIES,ARTHROSCOPIC10 reports
- ACUFEX 72204047BIT, SURGICAL8 reports
- ACUFEX 72204040BIT, SURGICAL7 reports
- ACUFEX 7205524ACCESSORIES,ARTHROSCOPIC7 reports
- ACUFEX 72201715ACCESSORIES,ARTHROSCOPIC7 reports
- ACUFEX 72204041BIT, SURGICAL6 reports
- ACUFEX 72204048BIT, SURGICAL5 reports
- ACUFEX 012036ACCESSORIES,ARTHROSCOPIC5 reports
- ACUFEX 012045ACCESSORIES,ARTHROSCOPIC5 reports
- ACUFEX 3312ACCESSORIES,ARTHROSCOPIC5 reports
- ACUFEX 7209494ACCESSORIES,ARTHROSCOPIC5 reports
- ACUFEX 72201733ACCESSORIES,ARTHROSCOPIC5 reports
- ACUFEX 7207201ACCESSORIES,ARTHROSCOPIC4 reports
- ACUFEX 7205517ACCESSORIES,ARTHROSCOPIC4 reports
- ACUFEX 72204050BIT, SURGICAL3 reports
- ACUFEX 7207047ACCESSORIES,ARTHROSCOPIC3 reports
- ACUFEX 7207598ACCESSORIES,ARTHROSCOPIC3 reports
- ACUFEX 7208686INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- ACUFEX 72201731Sterilization wrap containers, trays, cassettes & other accessories3 reports
- ACUFEX 72201717ACCESSORIES,ARTHROSCOPIC3 reports
- ACUFEX 72204049BIT, SURGICAL2 reports
- Acufex 71935072ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 72205103SUPPORT, PATIENT POSITION2 reports
- ACUFEX 010912ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 012016ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 012020ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 012034ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 012058ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 014723ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 010600ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 012705ARTHROSCOPE2 reports
- ACUFEX 013499INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- ACUFEX 7207193Screw, fixation, bone2 reports
- ACUFEX 7207200ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 7205525ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 7205519ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 7207340Accessories, operating-room, table (kit)2 reports
- ACUFEX 7209491ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 72201713ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 72201716ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 72201732ACCESSORIES,ARTHROSCOPIC2 reports
- ACUFEX 72203450ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 72203169ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 72204038BIT, SURGICAL1 report
- ACUFEX 72204039BIT, SURGICAL1 report
- ACUFEX 013219DACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 72205104COMPONENT, TRACTION, NON-INVASIVE1 report
- ACUFEX 72205101SUPPORT, PATIENT POSITION1 report
- ACUFEX 010801ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 010901ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 010913ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 012015ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 012030ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 012031ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 012046ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 012051ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 013661INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- ACUFEX 013663INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- ACUFEX 014724ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 010620ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 010640ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 010650ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 013546INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- ACUFEX 013660INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- ACUFEX 013662INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- ACUFEX 013977ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207048ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207049ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207083ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207295ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207282ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207284ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ACUFEX 7207600ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207601ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207602ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7207672ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 7209492ACCESSORIES,ARTHROSCOPIC1 report
- ACUFEX 72201885ACCESSORIES,ARTHROSCOPIC1 report
Recent ACUFEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHEN ONE (1) RETROGRADE DRL 9MM WAS INSERTED INTO THE TIBIA TO CREATE THE TUNNEL, WHILE INSIDE OF THE JOINT, THE WING WAS ATTEMPTED TO BE OPENED, IT DETACHED FROM THE RETROGRADE DRL 9MM. THE PIECES WERE COMPLETELY REMOVED USING ARTHROSCOPIC FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570304 ↗MalfunctionJun 10, 2026Break
IT WAS REPORTED THAT, DURING SURGERY OF KNEE ARTHROSCOPY + LCA + MENISCUS SUTURE, ONE (1) AIMER ENDOFEMORAL GUIDE BROKE INSIDE THE PATIENT, AND THE BROKEN PART WAS COMPLETELY REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465480 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT, DURING A MENISCUS TRANSPLANT SURGERY, THE DRILLING TIP OF THE RETROGRADE DRILL HAD SHEARED OFF DRILL SHAFT. DRILL TIP COULD NOT BE RETRIEVED AND REMAINED IN THE BONE. 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 25355396 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE PUNCH BASKET BROKE IN THE DOCTOR'S HAND WHILE BEING USED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230837 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT A PUNCH BASKET BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203757 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, AN ENDOFEMORAL AIMER BROKE IN HALF. ALL PIECES WERE RETRIEVED USING A GRASPER. 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 25203587 ↗InjuryMay 18, 2026Fracture
IT WAS REPORTED THAT, AFTER A PCL RECONSTRUCTION PROCEDURE, WHILE AN X-RAY WAS DONE, IT WAS NOTICED THAT, DURING THE SURGERY, WHEN ONE (1) GUIDE WIRE WAS INSERTED INTO THE TIBIA, THE DISTAL TIP WAS FRACTURED AND REMAINED EMBEDDED WITHIN THE BONE. THE PIECE WAS LEFT IN THE PATIENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 25202331 ↗MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, A PUNCH BASKET DUCKBILL BROKE INTRAOPERATIVELY. NO PARTS REMAINED INSIDE THE PATIENT AND THE JOINT WAS NOT DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24918601 ↗InjuryApr 17, 2026Break
IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY, THE LOWER PART OF THE PUNCH BASKET BROKE INSIDE THE PATIENT. THE BROKEN FRAGMENT COULD NOT BE REMOVED FROM THE PATIENT. A POSTOPERATIVE CONTROL X-RAY WAS PERFORMED, WHICH SHOWED A FRAGMENT LODGED IN THE POSTERIOR PART OF THE JOINT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, WITH A DELAY EQUAL TO 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 24911855 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY, THE LOWER PART OF THE PUNCH BASKET BROKE DURING THE MENISCAL RESECTION. THE BROKEN PIECE WAS LOCATED AND REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 10 MINUTES DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896049 ↗MalfunctionApr 8, 2026Failure to Align
IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH MENISCAL SUTURE, WHEN USING THE DRILL BIT AND SLEEVE IT DID NOT PASS THROUGH ONE (1) ACUFEX DIRECTOR ANGLED BULLET. SURGEON HAD TO DRILL SEVERAL TIMES WITH THE GUIDE. THE PROCEDURE WAS PERFORMED, WITH A DELAY GREATER THAN 30 MIN, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation
MAUDE report 24818285 ↗MalfunctionFeb 27, 2026Break; Positioning Failure
IT WAS REPORTED THAT DURING A KNEE ARTROSCOPY AND LCA MENISCUS SUTURE, THE RETROGRADE DRILL DID NOT OPEN AND IMMEDIATELY BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477396 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT DURING A ACL PROCEDURE, THE TIP OF THE 8MM RETROGRADE DRILL BROKE. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431228 ↗MalfunctionFeb 14, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE RETROGRADE DRILL GUIDE WIRE WAS USED FOR PASSING AND IT BROKE IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341332 ↗MalfunctionFeb 9, 2026Break; Mechanical Jam
IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE BLADE OF ONE (1) ACUFEX TRUNAV RETROGRADE DRILL COULD NOT ROTATE BECAUSE IT HAD A BROKEN PART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298953 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page