NA 03.133.175Recalls & reported problems
Synthes GmbH · 2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC · Class 1
Quick summary
This Synthes hex driver shaft is a self-retaining screwdriver shaft used to drive screws. Most of the 125 reports describe the shaft being twisted or bent, and most say no patient was affected. The reports include no deaths and no injuries. Reports rose to 33 in the last 12 months from 9 in the previous 12. 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
- 124
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10886982269874), received between Mar 8, 2021 and Aug 13, 2026 — classified as 124 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (114 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/Bent114
- Break7
- Device-Device Incompatibility7
- Material Deformation2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233997 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233771 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233763 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233758 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233751 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233690 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233441 ↗MalfunctionJun 1, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS DON'T HOLD WHEN WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25347442 ↗MalfunctionApr 27, 2026Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NOT FITTING INTO SCREWS. PLATE'S LOCKING HOLES DID NOT ALLOW THE LOCKING SCREWS TO THREAD INTO THE PLATE, CAUSING THE SCREWS TO SPIN WITHOUT ENGAGING. THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO REPORTED PATIENT OR USER HARM OR CLINICAL CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25008953 ↗MalfunctionApr 27, 2026Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NOT FITTING INTO SCREWS. PLATE'S LOCKING HOLES DID NOT ALLOW THE LOCKING SCREWS TO THREAD INTO THE PLATE, CAUSING THE SCREWS TO SPIN WITHOUT ENGAGING. THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO REPORTED PATIENT OR USER HARM OR CLINICAL CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25008919 ↗MalfunctionApr 27, 2026Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NOT FITTING INTO SCREWS. PLATE'S LOCKING HOLES DID NOT ALLOW THE LOCKING SCREWS TO THREAD INTO THE PLATE, CAUSING THE SCREWS TO SPIN WITHOUT ENGAGING. THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO REPORTED PATIENT OR USER HARM OR CLINICAL CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25008909 ↗MalfunctionApr 27, 2026Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NOT FITTING INTO SCREWS. PLATE'S LOCKING HOLES DID NOT ALLOW THE LOCKING SCREWS TO THREAD INTO THE PLATE, CAUSING THE SCREWS TO SPIN WITHOUT ENGAGING. THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO REPORTED PATIENT OR USER HARM OR CLINICAL CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25008887 ↗MalfunctionApr 27, 2026Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NOT FITTING INTO SCREWS. PLATE'S LOCKING HOLES DID NOT ALLOW THE LOCKING SCREWS TO THREAD INTO THE PLATE, CAUSING THE SCREWS TO SPIN WITHOUT ENGAGING. THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO REPORTED PATIENT OR USER HARM OR CLINICAL CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25008876 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE ROUNDED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561524 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE ROUNDED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561520 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE ROUNDED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561518 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE ROUNDED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561496 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE ROUNDED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561491 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT SCREWDRIVERS WERE ROUNDED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561461 ↗MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH PHILOS FOR THE PROXIMAL HUMERUS. DURING THE SURGERY, THE NURSE ATTACHED THE AIMING DEVICE TO THE PHILOS 3-HOLE PLATE USING A HEXAGONAL SCREWDRIVER. AFTER THE SCREWS WERE INSERTED, THE SURGEON TRIED TO REMOVE THE AIMING DEVICE WITH A HEXAGONAL SCREWDRIVER, BUT THE SCREW SPUN FREELY AND THE AIMING DEVICE COULD NOT BE REMOVED FROM THE PLATE. THE SURGEON TRIED TO GRIP THE SCREW OF THE AIMING DEVICE WITH PLIERS AND TURN IT, BUT IT DIDN'T WORK. THE AIMING DEVICE WAS SUCCESSFULLY REMOVED FROM THE PLATE USING REMOVAL FORCEPS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OVER A THIRTY MINUTE DELAY. THE SURGEON POINTED OUT THAT THE SCREW OF THE AIMING DEVICE OR THE SCREWDRIVER MAY BE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429310 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE PRODUCTS ARE NOT WORKING PROPERLY/HAVE BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085489 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE PRODUCTS ARE NOT WORKING PROPERLY/HAVE BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085488 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE PRODUCTS ARE NOT WORKING PROPERLY/HAVE BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085487 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE PRODUCTS ARE NOT WORKING PROPERLY/HAVE BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085484 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE PRODUCTS ARE NOT WORKING PROPERLY/HAVE BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085481 ↗
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.