IMHS 71665014Recalls & reported problems
Smith & Nephew, Inc. · SET SCREW DRIVER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew set screw driver is a surgical instrument used to tighten and release the set screws that hold together bone fixation implants during internal fixation surgery. The reports mostly describe the tool breaking, snapping at the shaft or elbow joint, or coming apart when small pins, springs, or screws holding its two halves loosen or fall out during use. In 48 reports there were no deaths and 2 injuries. 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
- 48
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 03596010518989), received between Dec 14, 2018 and May 25, 2026 — classified as 2 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Break” (19 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break19
- Detachment of Device or Device Component11
- Fracture11
- Material Separation5
- Solder Joint Fracture2
- Defective Component1
- Loose or Intermittent Connection1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 48 reports, 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 ↗MalfunctionDec 23, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERTAN CASE, A SET SCREW DRIVER BROKE WHILE TIGHTENING THE SET SCREW. ALL PIECES RETRIEVED. THERE WAS NOTHING LEFT IN THE PATIENT. THE SET SCREW DRIVER BROKE AFTER IT WAS USED TO TIGHTEN THE SCREW. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18389810 ↗MalfunctionNov 15, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERTAN NAIL PROCEDURE, ONE (1) SET SCREW DRIVER SNAPPED AT THE END OF TIGHTENING. BOTH PIECES WERE RECOVERED AND NOTHING REMAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141334 ↗MalfunctionOct 10, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PIN HOLDING THE FLEXIBLE SCREWDRIVER TOGETHER IS LOOSE AND HAS FALLEN APART. THE PROCEDURE WAS COMPLETED WITHOUT 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 17907645 ↗MalfunctionJul 18, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT, DURING SURGERY, A SET SCREW DRIVER BROKE AND STRIPPED FROM OVER USE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15038097 ↗MalfunctionJun 8, 2022Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE BALL JOINT IN THE SET SCREW DRIVER WAS NOTICED TO BE BREAKING WHILE OUTSIDE THE PATIENT. THE PROCEDURE CONTINUED WITH THE SAME DEVICE, WITHOUT A DELAY OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14640256 ↗MalfunctionApr 25, 2022Material Separation; Material Separation
IT WAS REPORTED THAT, DURING A LAB, A HINGE PIN FELL OUT OF THE SET SCREW DRIVER. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192403 ↗MalfunctionMar 31, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, A SET SCREW DRIVER FELL INTO TWO PIECES, THE SCREW HOLDING IT TOGETHER IS BELIEVED TO HAVE DISLODGED. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13961626 ↗MalfunctionMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A SET SCREW DRIVER FELL APART, A PIN THAT LINKS THE JOINT TOGETHER FELL OUT. IT IS UNKNOWN IF THIS CAUSED A DELAY AND HOW THE SURGERY WAS FINISHED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869839 ↗MalfunctionJan 5, 2022Break; Break
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, THE PIN OF A SET SCREW DRIVER CAME OUT CAUSING IT TO COME APART. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13170457 ↗MalfunctionDec 30, 2021Fracture; Fracture
IT WAS REPORTED THAT, DURING INSPECTION FOR SURGERY, THE SET SCREW DRIVER WAS FOUND IN TWO PIECES. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13120319 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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