NA 314.05Recalls & reported problems
Synthes GmbH · CANNULATED 4.0MM HEXAGONAL SCREWDRIVER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes cannulated hexagonal screwdriver is a surgical hand tool. Its 152 adverse event reports include 6 injuries and no deaths; many describe the driver breaking, bending, or cracking, and handles leaving brown stains after sterilization. Reports fell to 4 in the past 12 months from 14 before. 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
- 154
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 10886982188410), received between Dec 30, 2016 and Sep 24, 2026 — classified as 6 injuries, 148 malfunctions.
The most frequently reported specific device problem is “Break” (72 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
- Break72
- Material Twisted/Bent39
- Device-Device Incompatibility17
- Material Deformation12
- Contamination /Decontamination Problem7
- Naturally Worn5
- Crack4
- Material Fragmentation3
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- No Consequences Or Impact To Patient31
- No Patient Involvement29
- No Known Impact Or Consequence To Patient16
- No Code Available6
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Device-Device Incompatibility; Material Twisted/Bent
It was reported that the screwdriver doesn¿t sit right. There was a surgical delay of ten (10) minutes. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882993 ↗MalfunctionAug 14, 2026Break; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257537 ↗MalfunctionMar 3, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE END OF THE CANNULATED DRIVER WAS ROUNDED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500515 ↗MalfunctionJan 30, 2026Contamination /Decontamination Problem
IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223956 ↗MalfunctionDec 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED ON (B)(6) 2025 THAT THE ONE SCREWDRIVER HANDLE LEACHES BROWN RESIDUE. THE SECOND SCREWDRIVER'S TIP IS TWISTED/TORQUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730179 ↗MalfunctionNov 26, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE EVENT WAS POST OPERATIVE. THE SCREW DRIVERS WERE BENT BY THE TIME THEY RECEIVED THEM BACK IN CENTRAL STERILE. THERE WAS NO PATIENT CONSEQUENCES. THE PATIENT DID NOT REQUIRE ANY REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656948 ↗MalfunctionSep 8, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE 4.0 CANNULATED DRIVER WAS BROKEN AND WAS THROWN IN THE TRASH BY STAFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994505 ↗MalfunctionSep 8, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.0 CANNULATED DRIVER WAS BROKEN AND WAS THROWN IN THE TRASH BY STAFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994497 ↗MalfunctionAug 29, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE SCREWDRIVER HEAD WAS NOT ENGAGING IN THE SCREW. AFTER INSPECTION THE CANNULATED SCREWDRIVER HEAD WAS CRACKED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED AND NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22925749 ↗MalfunctionJul 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ARE LEAVING A BROWN STAIN IN POUCHES AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460876 ↗MalfunctionJun 9, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ON MAY 15,2025 THE SCREWDRIVER BENT INSIDE WIRE WON¿T FIT THROUGH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22169192 ↗MalfunctionMay 13, 2025Break; Break
IT WAS REPORTED THAT THE 4.0 CANNULATED SCREWDRIVER BROKE POST-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22008767 ↗MalfunctionApr 29, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON SAID THE SCREWDRIVER SHAFT IS STRIPPED. SURGEON GRABBED A DIFFERENT SCREWDRIVER. NO SURGICAL DELAY AND NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21930769 ↗MalfunctionMar 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, THE SCREWDRIVER HEAD WAS BENT, IT WOULDN'T GO OVER THE WIRE. THE SCREWDRIVER THREADS WERE SNAPPED OFF. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718401 ↗MalfunctionFeb 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP INSPECTION REVEALED THAT SEVERAL SCREWDRIVERS WERE STRIPPED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378725 ↗MalfunctionFeb 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP INSPECTION REVEALED THAT SEVERAL SCREWDRIVERS WERE STRIPPED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378721 ↗MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TIP OF THE SCREWDRIVER IS WORN, AND THE GUIDE PIN WILL NO LONGER FIT THROUGH THE CANNULATION. THIS WAS FOUND IN STERILE PROCESSING DURING THE CLEANING PROCESS, SO IT DID NOT AFFECT A CASE. A REPLACEMENT IS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118733 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVER HANDLE OUT OF THE 7.3 CANNULATED SCREW SET BROKE AND I NEED A REPLACEMENT. THERE WAS NO PATIENT HARM, AND MINIMAL DELAY IN THE SURGERY. ANOTHER TRAY WITH THE SAME SCREWDRIVER IN IT WAS OPENED AND USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118712 ↗MalfunctionDec 9, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20879244 ↗MalfunctionNov 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE END OF THE CANNULATED HEX DRIVER IS ROUNDED. THERE WAS NO PATIENT CONSEQUENCES AND NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694850 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN SCREWDRIVER TIP AND BROKEN CABLE TENSIONER INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20202343 ↗MalfunctionMar 20, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE INVOLVING A CANNULATED SCREW, IT WAS DISCOVERED THAT THE HEAD OF THE SCREWDRIVER IN QUESTION WAS STRIPPED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES AND NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A CANNULATED 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942036 ↗MalfunctionMar 15, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREW DRIVER BROKEN WHILE DOING A HARDWARE REMOVAL. THERE WERE NO PATIENT OUTCOMES REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ANOTHER SCREWDRIVER WAS USED. FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913939 ↗MalfunctionMar 13, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT PLATES WERE IMPLANTED IN THE PATIENT, THE LOCKING SCREWS DID NOT LOCK IN 1-2 HOLES OF THE PL AND MEDIAL PLATES SO THOSE PLATE HOLES WERE NOT FILLED. THE SURGEON INITIALLY USED A VA GUIDE BUT LATER USED A NON LOCKING DRILL GUIDE. UNSURE IF IT¿S BECAUSE HE USED A METAPHYSEAL SCREW FIRST TO SUCK THE PLATE DOWN, AND THEN CHANGED FOR A VAL. WE¿VE HAD ISSUES WITH THIS PLATE NOT LOCKING, SURGEON DID NOT WANT PATIENT TO BE CHARGED. WHILE INSERTING CORTICAL SCREWS AND A 7.3 CANNULATED FOR THE OLECRANON OSTEOTOMY HE ALSO COMPLAINED OF THE SCREWDRIVER HEADS BEING STRIPPED OR WARPED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18897658 ↗MalfunctionMar 7, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, TIP OF SCREWDRIVER BENT WARPED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18859349 ↗
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 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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