NA 03.424.302Recalls & reported problems
Synthes GmbH · SCREWDRIVER SHAFT T8 AO QC/ 105MM · Class 1
Quick summary
This Synthes screwdriver is used to place screws. The 24 reports mainly describe the shaft twisting or bending, breaking, or failing to grip screws; one mentions a foreign body in a patient. There were no deaths or injuries, and no recalls name this device. Reports rose from 7 in the previous 12 months to 17 in the latest 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982336040), received between Feb 24, 2025 and Sep 29, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (21 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/Bent21
- Break6
- Device-Device Incompatibility4
- Calibration Problem2
- Crack2
- Entrapment of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Entrapment of Device
It was reported that the Screwdriver broke during a case and the broken fragment remained in the head of the Screw.
Patient problems: Foreign Body In Patient
MAUDE report 50933211 ↗MalfunctionSep 3, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595537 ↗MalfunctionSep 3, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595526 ↗MalfunctionAug 24, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412960 ↗MalfunctionAug 24, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408520 ↗MalfunctionAug 5, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143171 ↗MalfunctionAug 4, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128661 ↗MalfunctionApr 13, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS INADEQUATE STORAGE OF SCREWS IN VOLT MINI FRAG. THE DRIVER WAS NOT CAPTURING AND STARTING TO STRIP. THERE WAS DAMAGED PACKAGING FOR RFNA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860271 ↗MalfunctionApr 13, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS INADEQUATE STORAGE OF SCREWS IN VOLT MINI FRAG. THE DRIVER WAS NOT CAPTURING AND STARTING TO STRIP. THERE WAS DAMAGED PACKAGING FOR RFNA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859435 ↗MalfunctionApr 13, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS INADEQUATE STORAGE OF SCREWS IN VOLT MINI FRAG. THE DRIVER WAS NOT CAPTURING AND STARTING TO STRIP. THERE WAS DAMAGED PACKAGING FOR RFNA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859390 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED DURING INSPECTION, IT WAS NOTED THE SCREWDRIVER WAS NOT HOLDING THE CORRESPONDING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559793 ↗MalfunctionMar 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON STRUGGLED TO ENGAGE THE SCREWDRIVER SHAFT INTO THE RECESS OF THE SCREWS DURING A PROCEDURE. ANOTHER SCREWDRIVER FROM THE SET WAS USED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559013 ↗MalfunctionJan 26, 2026Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A VOLT DISTAL RADIUS CASE, ONE OF THE SURGEONS HAD TROUBLE USING SEVERAL T8 SCREWDRIVERS WHEN TURNING SCREWS. THESE SCREWDRIVERS ALL APPEARED TO HAVE SOME DAMAGE ON THEIR TIPS THAT ENGAGE WITH THE SCREWS. IT IS NOT KNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176519 ↗MalfunctionJan 26, 2026Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A VOLT DISTAL RADIUS CASE, ONE OF THE SURGEONS HAD TROUBLE USING SEVERAL T8 SCREWDRIVERS WHEN TURNING SCREWS. THESE SCREWDRIVERS ALL APPEARED TO HAVE SOME DAMAGE ON THEIR TIPS THAT ENGAGE WITH THE SCREWS. IT IS NOT KNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176518 ↗MalfunctionJan 26, 2026Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A VOLT DISTAL RADIUS CASE, ONE OF THE SURGEONS HAD TROUBLE USING SEVERAL T8 SCREWDRIVERS WHEN TURNING SCREWS. THESE SCREWDRIVERS ALL APPEARED TO HAVE SOME DAMAGE ON THEIR TIPS THAT ENGAGE WITH THE SCREWS. IT IS NOT KNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176516 ↗MalfunctionJan 26, 2026Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A VOLT DISTAL RADIUS CASE, ONE OF THE SURGEONS HAD TROUBLE USING SEVERAL T8 SCREWDRIVERS WHEN TURNING SCREWS. THESE SCREWDRIVERS ALL APPEARED TO HAVE SOME DAMAGE ON THEIR TIPS THAT ENGAGE WITH THE SCREWS. IT IS NOT KNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176514 ↗MalfunctionJan 5, 2026Break
IT WAS REPORTED THAT DURING TIGHTENING OF 2.4 BENDING PINS, THE NARROW TIPS OF THE T8 SCREWDRIVER BLADES (BOTH LONG AND SHORT) BROKE, RENDERING THEM UNUSABLE FOR SCREW INSERTION. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT SURGICAL DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959652 ↗MalfunctionDec 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND/OR BENT AND SOME SCREWS WOULD NOT LOCK IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889191 ↗MalfunctionDec 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND/OR BENT AND SOME SCREWS WOULD NOT LOCK IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889182 ↗MalfunctionDec 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND/OR BENT AND SOME SCREWS WOULD NOT LOCK IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889096 ↗MalfunctionAug 28, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT SCREWDRIVER STRIPPED AND DID NOT GRAB THE SCREW PROPERLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22917385 ↗MalfunctionJul 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, THE SCREW DRIVERS AND ONE HANDLE ARE BROKEN, NEED REPLACEMENT ASAP. DRIVER TIPS ARE TWISTED AND HAVE DAMAGED THREADS. SCREW DRIVER HANDLE IS STUCK AND WILL NOT RELEASE. ITEMS ARE AVAILABLE FOR RETURN. NO DELAY OR PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577384 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT TIP BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. FRAGMENT GENERATED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22556276 ↗MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER TIPS WERE WORN OUT AND NO LONGER WORKING PROPERLY. A SCREW HEAD WAS STRIPPED AND HAD TO BE REMOVED CAUSING A MINIMAL DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340338 ↗MalfunctionMay 14, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE PUT ON HAND WITH TOO MUCH TORQUE AND WERE STRIPPED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022659 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.