NA 03.100.033Recalls & reported problems
Synthes GmbH · 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes screwdriver is a tool for inserting surgical screws. The 43 reports mostly describe the tip or shaft becoming rounded, bent, twisted, incompatible with other tools, or breaking; no deaths or injuries were reported. No recalls name this device. Reports increased from 7 in the previous 12 months to 12 in the most recent 12 months.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10886982070821), received between Oct 3, 2018 and Jul 28, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (35 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
- Material Twisted/Bent35
- Device-Device Incompatibility6
- Break4
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057422 ↗MalfunctionJul 28, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057417 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE ENDS OF THE SCREWDRIVER TIPS WERE ROUNDED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174378 ↗MalfunctionMay 8, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4NM TORQUE LIMITERS NO LONGER LATCH ONTO THE AO REAMING COUPLER. THE CABLE CUTTER HAS AN INTERNAL SCREW LOOSE. THE LONG PELVIC 2.5 DRIVERS WERE ROUNDED OFF AT THE TIPS. THE SMALL FRAG DEPTH GAUGES HAVE BROKEN TIPS. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127456 ↗MalfunctionMay 8, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4NM TORQUE LIMITERS NO LONGER LATCH ONTO THE AO REAMING COUPLER. THE CABLE CUTTER HAS AN INTERNAL SCREW LOOSE. THE LONG PELVIC 2.5 DRIVERS WERE ROUNDED OFF AT THE TIPS. THE SMALL FRAG DEPTH GAUGES HAVE BROKEN TIPS. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126578 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE ROUNDED OFF PER INSPECTION OF SET POST OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944608 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE ROUNDED OFF PER INSPECTION OF SET POST OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944600 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE ROUNDED OFF PER INSPECTION OF SET POST OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944598 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE ROUNDED OFF PER INSPECTION OF SET POST OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944597 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE ROUNDED OFF PER INSPECTION OF SET POST OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944594 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE ROUNDED OFF PER INSPECTION OF SET POST OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944591 ↗MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED DURING THE PROCEDURE, IT WAS OBSERVED THAT ALL 2.5 MM DRILL BITS WERE DULL, AND ALL SCREWDRIVERS NO LONGER RETAINED THEIR HEXAGONAL SHAPE, PREVENTING THE CORRECT PLACEMENT OF THE SCREWS. THE PATIENT WAS NOT AFFECTED, BUT THERE WAS A DELAY IN TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788617 ↗MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PELVIC HEX SCREWDRIVERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318436 ↗MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PELVIC HEX SCREWDRIVERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318433 ↗MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PELVIC HEX SCREWDRIVERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318431 ↗MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PELVIC HEX SCREWDRIVERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318430 ↗MalfunctionJan 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DOCTOR IS DISSATISFIED WITH THE SCREWDRIVER AND THE HOLDING SLEEVE, SINCE THE SHEATH DOES NOT SLIDE COMPLETELY THROUGH THE SCREWDRIVER, WHICH MAKES INSERTION OF THE SCREW DIFFICULT AND OBSTRUCTS THE SURGICAL FIELD, WHICH IS REDUCED IN THE PELVIS. THE SURGERY ENDS SUCCESSFULLY. THE 2.5 DRILL BITS ARE VERY WORN. THE SPECIALIST WAS UPSET AND DECIDED TO BEND 2 DRILL BITS AND REQUESTED THAT NEW DRILL BITS BE SENT.
Patient problems: Insufficient Information
MAUDE report 21252927 ↗MalfunctionJan 17, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON JAN 8, 2025 THE SCREWDRIVERS ARE STARTING TO DEFORM AND STRIP OUT. TRUNK STOCK FROM PELVIS SET. THERE WAS NO CASE INVOLVED. IT WAS NOTICED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179163 ↗MalfunctionJan 17, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025 THE SCREWDRIVERS ARE STARTING TO DEFORM AND STRIP OUT. TRUNK STOCK FROM PELVIS SET. THERE WAS NO CASE INVOLVED. IT WAS NOTICED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179156 ↗MalfunctionMay 15, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON APRIL 17, 2024 DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN, IT WAS IDENTIFIED THAT THE TWO INSTRUMENTS ARE STUCK TOGETHER AND UNABLE TO BE TAKEN APART. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19323859 ↗MalfunctionApr 16, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE END OF THE HEX WAS ROUNDED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19117201 ↗MalfunctionApr 8, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON MARCH 21 2024, 3.5MM SCREWDRIVER SHAFT LONG WITH VPC# 03.100.033 WAS STRIPPED. THE SCREW COULD NOT BE ADVANCED BECAUSE OF THIS. A DIFFERENT SCREWDRIVER WAS USED TO FINISH THE CASE SUCCESSFULLY WITHOUT ANY COMPLICATIONS OR DELAYS. THIS REPORT IS FOR ONE 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19060343 ↗MalfunctionMar 14, 2024Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON FEBRUARY 26, 2024, THAT THE DRILLS ARE NOT SHARP, AND THE SURGERY IS PERFORMED WITHOUT PROBLEMS SINCE, IN ADVANCE, AT THE REQUEST OF THE SPECIALIST, TWO STOCK DRILLS ARE SENT TO BE STERILIZED, AND THE SURGERY CAN BE PERFORMED WITH THESE. THERE IS DISAGREEMENT AMONG THE SPECIALISTS, WHO SAY THAT THE DRILL BITS FROM THE STREET EQUIPMENT ALWAYS ARRIVE BAD. THE PATIENT IS NOT AFFECTED. THE SCREWDRIVER SHOWS WEAR, AND THE SPECIALIST INDICATES THAT HE ROTATES THE SCREWS. THE SCREWS ARE TIGHTENED WITH ANOTHER SCREWDRIVER IN THE TEAM, BUT ACCORDING TO THE SPECIALIST, THIS ONE, BECAUSE IT HAS A THINNER HANDLE, IS NOT COMFORTABLE FOR HIM. THE SURGERY IS PERFORMED WITH A DELAY OF 2 MINUTES, GENERATING COMPLIANCE IN THE SPECIALIST. THIS REPORT IS FOR ONE (1)SCRDRIVERSHAFT-HEX F/SCR Ø3.5 L250 THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18902327 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT ON DECEMBER 27, 2023, A SCREWDRIVER SNAPPED AT THE LASER LINE WHILE INSERTING A SCREW. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18551161 ↗MalfunctionSep 28, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, BOTH THE 2.5 HEX POWER SCREWDRIVER AND 2.5 HEX HAND HELD SCREWDRIVER HEADS STRIPPED WHILE PUTTING IN SCREWS. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTED PATIENT CONSEQUENCES AND NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM SCREWDRIVER SHAFT HEXAGONAL-LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17833700 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page