EVOS 71175072Recalls & reported problems
Smith & Nephew, Inc. · EVOS SMALL 2.5MM FIXED HANDLE LINEAR HEX DRIVER · Class 1
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew EVOS small fixed-handle hex driver, a surgical screwdriver used in plating and internal fixation surgery, has 336 reports, 53 of them injuries and no deaths. The reports mostly describe the driver breaking or fracturing at the tip during surgery, with some fragments needing retrieval from the patient. Reports in the last 12 months number 8, down from 17 in the previous 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 336
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 336 adverse event reports that list this exact device (DI 00885556636046), received between Sep 13, 2018 and Jun 20, 2026 — classified as 53 injuries, 283 malfunctions.
The most frequently reported specific device problem is “Break” (197 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.
Reports received per month
Most reported problems
Device problems
- Break197
- Fracture124
- Material Deformation7
- Crack2
- Device Damaged by Another Device2
- Material Twisted/Bent2
- Naturally Worn2
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions274
- No Consequences Or Impact To Patient32
- No Known Impact Or Consequence To Patient15
- No Patient Involvement9
- Foreign Body In Patient4
- Injury3
- Device Embedded In Tissue or Plaque1
- No Code Available1
Recent adverse event reports
The 25 most recent of 336 reports, in the reporter's own words as published by the FDA.
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 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 ↗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 ↗MalfunctionMar 7, 2026Fracture
IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE TIP OF TWO (2) 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 24541025 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR (B)(6). IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483265 ↗MalfunctionFeb 20, 2026Fracture
IT WAS REPORTED THAT DURING AN ORIF FEMUR PROCEDURE, THE TIP OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF WHILE TRYING TO BEND THE PLATE. 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 24400236 ↗MalfunctionNov 24, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE TIP OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF. 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 23640425 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN THE SCREW WAS BEING INSERTED, ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR WAS TORQUED AND BROKE. THE BROKEN PIECE FELL INTO THE PATIENT¿S WOUND AND WAS COMPLETELY REMOVED USING A NEEDLE HOLDER. 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 23475934 ↗MalfunctionSep 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF INSIDE THE LOCKING TOWER, THE BROKEN PIECE WAS DISCARDED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932785 ↗MalfunctionJul 21, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, THE TIP OF THE EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF. IT IS UNKNOWN IF PIECES FELL IN PATIENT´S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22562183 ↗MalfunctionJul 20, 2025Break; Break
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE TIP OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22552294 ↗MalfunctionJun 27, 2025Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress
IT WAS REPORTED THAR, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR WAS ROUNDED AND SNAPPED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346218 ↗MalfunctionJun 5, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE HEAD (TIP) OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF. THE BROKEN PIECE WAS EASILY REMOVED FROM THE WOUND MANUALLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22151144 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT, WHILE SCREWING DURING AN INTERNAL FIXATION, THE TIP OF TWO (2) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22070411 ↗MalfunctionApr 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP ON ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR FELL OFF. PIECES FELL INTO THE WOUND; HOWEVER, THEY WERE REMOVED USING TWEEZERS AND ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938992 ↗MalfunctionApr 20, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING INTERNAL FIXATION, ONE (1) EVOS SM 2.5 MM FIXED HANDLE LINEAR HEX DRIVER BROKE WHILE ATTEMPTING TO BEND THE PLATE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING A S+N BACK UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870418 ↗MalfunctionApr 1, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT, USING FORCEPS, WITHOUT ANY INJURY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY TO PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749254 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE WHEN DOCTOR WAS USING HANDLE AS A TOMMY BAR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630815 ↗MalfunctionMar 3, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE WHILE TURNING SCREW. THE PIECE DID NOT GET STUCK IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504279 ↗MalfunctionFeb 26, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TREATMENT, ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21468861 ↗MalfunctionFeb 24, 2025Fracture; Fracture
IT WAS REPORTED THAT, WHILE SCREWING DURING AN INTERNAL FIXATION, THE TIP OF TWO (2) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21448196 ↗MalfunctionFeb 7, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, ONE EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21339834 ↗MalfunctionJan 22, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE PLANNED REMOVAL PROCESS OF AN EVOS PLATE, THE TIP OF TWO (2) EVOS SM 2.5 MM FIXED HANDLE LINEAR HEX DRIVERS BROKE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208044 ↗MalfunctionDec 3, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A CLAVICLE PLATING, THE TIP OF A (1) EVOS SM 2.5 MM FIXED HANDLE LINEAR HEX DR BROKE OFF DURING SCREW INSERTION. THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833112 ↗MalfunctionNov 5, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY ONE (1) EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR- TIP BROKE OFF WHILE TRYING TO REMOVE SCREW, ALL PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20606633 ↗
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- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
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- NA 2274-02-000Depuy (Ireland) · SCREWDRIVER303 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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