EVOSRecalls & reported problems across all models
Smith & Nephew, Inc. · 190 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,360
- Deaths reported
- 0
- Injuries reported
- 295
- Recalls
- 1
We found 190 models of EVOS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 1,360 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2017 and Jun 29, 2026 — classified as 295 injuries, 1,065 malfunctions.
The most frequently reported specific device problem is “Break” (597 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
EVOS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 1, 2021Terminated
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Z-0363-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported EVOS problems
Device problems
- Break597
- Fracture366
- Material Twisted/Bent77
- Material Deformation73
- Connection Problem71
- Adverse Event Without Identified Device or Use Problem29
- Detachment of Device or Device Component26
- Mechanical Jam26
Patient problems
- No Clinical Signs, Symptoms or Conditions923
- No Consequences Or Impact To Patient123
- No Known Impact Or Consequence To Patient111
- No Patient Involvement56
- Foreign Body In Patient46
- No Information38
- Device Embedded In Tissue or Plaque34
- Failure of Implant30
EVOS models
190 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- EVOS 71175072SCREWDRIVER336 reports
- EVOS 71174934Guide, surgical, instrument149 reports
- EVOS 71174986SCREWDRIVER127 reports
- EVOS 71174985SCREWDRIVER57 reports
- EVOS 71175022INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT55 reports
- EVOS 72573101Plate, fixation, bone1 recall0 reports
- EVOS 71174930Guide, surgical, instrument46 reports
- EVOS 71175021INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT29 reports
- EVOS 71175069Screw, fixation, bone28 reports
- EVOS 71175078SCREWDRIVER25 reports
- EVOS 71175068Plate, fixation, bone21 reports
- EVOS 71174927SCREWDRIVER19 reports
- EVOS 71175077SCREWDRIVER19 reports
- EVOS 71174984SCREWDRIVER18 reports
- EVOS 71175073SCREWDRIVER18 reports
- EVOS 71174933SCREWDRIVER17 reports
- EVOS 71175041Guide, surgical, instrument16 reports
- EVOS 71174924Guide, surgical, instrument15 reports
- EVOS 71175023INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT15 reports
- EVOS 71174921SCREWDRIVER14 reports
- EVOS 71174922PLATE, FIXATION, BONE14 reports
- EVOS 71174910BIT, DRILL13 reports
- EVOS 71174959PLATE, FIXATION, BONE13 reports
- EVOS 71174928GAUGE, DEPTH9 reports
- EVOS 71174988Guide, surgical, instrument9 reports
- EVOS 71175098INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT8 reports
- EVOS 71174989Guide, surgical, instrument7 reports
- EVOS 71174987Guide, surgical, instrument6 reports
- EVOS 71175020INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- EVOS 71174911BIT, DRILL5 reports
- EVOS 71158093SCREWDRIVER5 reports
- EVOS 71174906BIT, DRILL4 reports
- EVOS 71174926SCREWDRIVER4 reports
- EVOS 71174932SCREWDRIVER4 reports
- EVOS 71175066Plate, fixation, bone4 reports
- EVOS 71175067Plate, fixation, bone4 reports
- EVOS 71175074SCREWDRIVER4 reports
- EVOS 71175044Screw, fixation, bone4 reports
- EVOS 71175088FORCEPS4 reports
- EVOS 72424746Screw, fixation, bone4 reports
- EVOS 72440808Plate, fixation, bone4 reports
- EVOS 72468203Plate, fixation, bone4 reports
- EVOS 71158104Plate, fixation, bone4 reports
- EVOS 71176002ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- EVOS 71174920SCREWDRIVER3 reports
- EVOS 72412418PLATE, FIXATION, BONE3 reports
- EVOS 71175047Guide, surgical, instrument3 reports
- EVOS 72413575Screw, fixation, bone3 reports
- EVOS 72463113Plate, fixation, bone3 reports
- EVOS 72440807Screw, fixation, bone3 reports
- EVOS 71175099ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- EVOS 72468204Plate, fixation, bone3 reports
- EVOS 71158103Plate, fixation, bone3 reports
- EVOS 71177733ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- EVOS 72585216Plate, fixation, bone3 reports
- EVOS 71177760ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- EVOS 71174901BIT, DRILL2 reports
- EVOS 71174905BIT, DRILL2 reports
- EVOS 72412014PLATE, FIXATION, BONE2 reports
- EVOS 72402410PLATE, FIXATION, BONE2 reports
- EVOS 72412415PLATE, FIXATION, BONE2 reports
- EVOS 72402010NPLATE, FIXATION, BONE2 reports
- EVOS 72403520Screw, fixation, bone2 reports
- EVOS 71175025INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- EVOS 71175079SCREWDRIVER2 reports
- EVOS 72413530Plate, fixation, bone2 reports
- EVOS 72413524NPlate, fixation, bone2 reports
- EVOS 72440806Screw, fixation, bone2 reports
- EVOS 72453605Plate, fixation, bone2 reports
- EVOS 72468104Plate, fixation, bone2 reports
- EVOS 72468304Plate, fixation, bone2 reports
- EVOS 71176007SCREWDRIVER2 reports
- EVOS 71177735ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- EVOS 71177752ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- EVOS 71177757ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- EVOS 71174904PIN, FIXATION, THREADED1 report
- EVOS 71174914PIN, FIXATION, THREADED1 report
- EVOS 71174923PLATE, FIXATION, BONE1 report
- EVOS 71174925PLATE, FIXATION, BONE1 report
- EVOS 72402010PLATE, FIXATION, BONE1 report
- EVOS 72402015PLATE, FIXATION, BONE1 report
- EVOS 72402021PLATE, FIXATION, BONE1 report
- EVOS 72412013PLATE, FIXATION, BONE1 report
- EVOS 72412015PLATE, FIXATION, BONE1 report
- EVOS 72402412PLATE, FIXATION, BONE1 report
- EVOS 72402414PLATE, FIXATION, BONE1 report
- EVOS 72402416PLATE, FIXATION, BONE1 report
- EVOS 72402430PLATE, FIXATION, BONE1 report
- EVOS 72402434PLATE, FIXATION, BONE1 report
- EVOS 72402444PLATE, FIXATION, BONE1 report
- EVOS 72412408PLATE, FIXATION, BONE1 report
- EVOS 72412416PLATE, FIXATION, BONE1 report
- EVOS 72412417PLATE, FIXATION, BONE1 report
- EVOS 72412422PLATE, FIXATION, BONE1 report
- EVOS 72412775PLATE, FIXATION, BONE1 report
- EVOS 72442454PLATE, FIXATION, BONE1 report
- EVOS 72442460PLATE, FIXATION, BONE1 report
- EVOS 72442722PLATE, FIXATION, BONE1 report
- EVOS 72402009NPLATE, FIXATION, BONE1 report
- EVOS 72412012NPLATE, FIXATION, BONE1 report
Recent EVOS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Break
IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE HOUSING WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25661895 ↗MalfunctionJun 20, 2026Fracture
IT WAS REPORTED THAT, DURING A PLATING SURGERY, ONE (1) EVOS SM 2.5 MM FIXED HANDLE LINEAR HEX DR SNAPPED AT THE HEX DRIVER END. THE PIECES WERE RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS THEN RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570355 ↗MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT, DURING A HARDWARE REMOVAL/EXPLANT THAT WAS PLANNED, ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE DURING A SCREW REMOVAL; SCREWS WERE JUST DIFFICULT TO REMOVE AFTER BEING IN FOR AN EXTENDED PERIOD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25470673 ↗MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT, DURING A HARDWARE REMOVAL/EXPLANT THAT WAS PLANNED, ONE (1) EVOS DRAD TI T7 LIN DRIVER SHAFT W/AO QC BROKE DURING A SCREW REMOVAL; SCREWS WERE JUST DIFFICULT TO REMOVE AFTER BEING IN FOR AN EXTENDED PERIOD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25470655 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE HOOK ON THE END OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE LONG BROKE AND UNABLE TO MEASURE ACCURATELY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25415627 ↗MalfunctionJun 2, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE END OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF WHILE TIGHTENING THE SCREW. ALL THE BROKEN PIECES WERE REMOVED AND ACCOUNTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25367787 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING A PLATE SURGERY, ONE (1) EVOS LARGE TGTR 4.5MM LOCKING GUIDE BROKE. 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 25342062 ↗MalfunctionMay 25, 2026Fracture
IT WAS REPORTED THAT, DURING A PROXIMAL TIBIA ORIF SURGERY, THE TIP OF ONE (1) T7 DRIVER SHAFT W/AO QC BROKE OFF WHILE PUTTING IN A SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273369 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC CHIPPED OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211737 ↗MalfunctionMay 3, 2026Break
IT WAS REPORTED THAT, DURING AN EVOS MINI FRAG SURGERY, THE DRILL BIT GOT STUCK IN ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND BROKE THE GUIDE WHEN TRYING TO REMOVE IT. 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 25062992 ↗MalfunctionApr 30, 2026Fracture
IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE TIP OF AN EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR SNAPPED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045199 ↗MalfunctionApr 28, 2026Fracture
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE OFF WHEN IT WAS DRILLING. ADDITIONALLY, BOTH SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS ARE BENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25013598 ↗MalfunctionApr 18, 2026Break
IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, ONE (1) DEPTH GAUGE FOR 2.0MM SCREWS BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919501 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT, DURING AN ANKLE ORIF SURGERY, WHILE DRILLING FOR A LAG SCREW, ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE WHILE APPLYING PRESSURE TO THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873218 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 2.0MM DRILL SHORT W/AO QC BROKE WHILE FINISHING THE DRILLING. THERE WAS NO FRACTURE TO THE PATIENT. 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 24789475 ↗
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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