IMHSRecalls & reported problems across all models
Smith & Nephew, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 12 models of IMHS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and May 25, 2026 — classified as 8 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Break” (26 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 IMHS problems
Device problems
- Break26
- Detachment of Device or Device Component11
- Fracture11
- Material Separation5
- Material Deformation2
- Solder Joint Fracture2
- Activation, Positioning or Separation Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient5
- Injury4
- Insufficient Information1
- No Information1
- No Patient Involvement1
IMHS models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMHS 71665014SCREWDRIVER48 reports
- IMHS 71152151ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- IMHS 71665036ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- IMHS 71665015ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- IMHS 115188APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- IMHS 71684090Screw, fixation, bone1 report
- IMHS 71683012RScrew, fixation, bone1 report
- IMHS 71661232Screw, fixation, bone1 report
- IMHS 71687029ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- IMHS 71665020Prosthesis, hip, femoral component, cemented, metal1 report
- IMHS 71687012ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- IMHS 71687111ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent IMHS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SMALL PIN THAT HOLD THE TWO PARTS OF ONE (1) SET SCREW DRIVER FELL OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 25273336 ↗MalfunctionFeb 14, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE SET SCREW DRIVER BROKE AS THE METAL SHAFT SNAPPED. ALL PARTS WERE RETRIEVED AS THE BROKEN PARTS FELL EXTERNAL TO THE PATIENT. 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 24341237 ↗MalfunctionFeb 14, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE SET SCREW DRIVER BROKE BECAUSE THE CROSS PIN THAT HOLDS THE TWO PIECES OF THE SET SCREW FELL OUT. ALL PARTS WERE RETRIEVED AS THE BROKEN PARTS FELL EXTERNAL TO THE PATIENT. 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 24341236 ↗MalfunctionFeb 14, 2026Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE SET SCREW DRIVER BROKE BECAUSE THE CROSS PIN THAT HOLDS THE TWO PIECES OF THE SET SCREW FELL OUT. ALL PARTS WERE RETRIEVED AS THE BROKEN PARTS FELL EXTERNAL TO THE PATIENT. 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 24341234 ↗MalfunctionFeb 10, 2026Fracture
IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) SET SCREW DRIVER BROKE AT THE ELBOW JOINT DURING STANDARD USAGE, NO PIECES FELL INSIDE PATIENT. 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 24310821 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A HIP ORIF SURGERY, THE SET SCREWDRIVER FELL APART/DISASSEMBLED AFTER IT WAS LOCKED THE SET SCREW, AS IT PULLED OUT THE DRIVER IT FELL APART. 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 23919217 ↗MalfunctionDec 2, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) SET SCREWDRIVER WAS SEPARATED IN MIDDLE. 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 23698751 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING NAIL EXTRACTION, WHEN RELEASING THE NAIL SAFETY LOCK, THE ARTICULATED SET SCREWDRIVER CAME LOOSE. THE SPRING AND THE SCREW THAT HELD IT, WERE DISASSEMBLED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399064 ↗MalfunctionOct 27, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A ORIF HIP/FEMUR ONE (1) SET SCREW DRIVER BROKE IN TWO PIECES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23398021 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGERY ONE (1) SET SCREW DRIVER BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364531 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) SET SCREWDRIVER WAS BROKEN WHILE TIGHTENING THE SET SCREW. 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 22199748 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, DISCOVERED THAT THE PIN OF THE SET SCREW DRIVER HOLDING THE SWIVEL DRIVER TO THE REST OF THE SHAFT IS POPPING OUT AND CAUSING THE DRIVER TO COME APART. 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 20127476 ↗MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE PIN OF THE SET SCREW DRIVER FELL OUT AND CAME APART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20078047 ↗MalfunctionFeb 29, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING SURGERY THE PORTION OF THE SET SCREW DRIVER WHICH PASSES THROUGH THE JOINT FELL APART. ALL PIECES WERE VISUALIZED AND RETRIEVED FROM THE PATIENT. SURGEON CONFIRMED THAT NO PIECES WERE LEFT VIA FLUROSCOPY. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18813632 ↗MalfunctionJan 5, 2024Break; Break
IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT ONE (1) SET SCREW DRIVER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451382 ↗
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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