MatrixNEURO 03.503.017Recalls & reported problems
Synthes GmbH · MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED · Class 1
All models of MatrixNEURO (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes MatrixNEURO screwdriver is a surgical instrument used to place small screws in skull surgery. Its 79 reports, with no deaths and no injuries, all describe malfunctions, mostly instruments bent or twisted and screwdrivers that did not fit the screws. Some reports describe old, worn instruments and a bent depth gauge giving wrong readings. Reports fell to 1 in the last 12 months from 6 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
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10887587011554), received between Feb 3, 2017 and Mar 26, 2026 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (52 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
- Material Twisted/Bent52
- Device-Device Incompatibility36
- Failure To Adhere Or Bond7
- Break1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Consequences Or Impact To Patient16
- Insufficient Information10
- No Known Impact Or Consequence To Patient4
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM WITH NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699287 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DEVICE IS OLD AND WORN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599764 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DEVICE IS OLD AND WORN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599758 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DEVICE IS OLD AND WORN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599748 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DEVICE IS OLD AND WORN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599744 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DEVICE IS OLD AND WORN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599743 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THE SETS WERE CONSIGNED AT THE HOSPITAL FOR MORE THAN FEW YEARS. INSTRUMENTS ARE OLD, WORN OFF. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS. THERE WAS NO PATIENT INVOLVEMENT OR SURGICAL DELAY. EVENT DATE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597072 ↗MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON WAS TRYING TO PLATE THE CRANIAL FLAP AND THE MATRIX NEURO SCREWS STARTED STRIPPING. SURGEON THOUGHT THAT EITHER THE SCREWS ARE DEFECTIVE OR THAT THE SCREW DRIVER SHAFTS ARE DEFECTIVE. SCREWS COLLECTED ALONG WITH THE SCREWDRIVER SHAFTS AND PUT IN AA SPECIMEN CUP TO BE SENT IN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MATRXNEUR SCRDRVR BLD HEX CPL/SLFRET/MD THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18979386 ↗MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON WAS TRYING TO PLATE THE CRANIAL FLAP AND THE MATRIX NEURO SCREWS STARTED STRIPPING. SURGEON THOUGHT THAT EITHER THE SCREWS ARE DEFECTIVE OR THAT THE SCREW DRIVER SHAFTS ARE DEFECTIVE. SCREWS COLLECTED ALONG WITH THE SCREWDRIVER SHAFTS AND PUT IN AA SPECIMEN CUP TO BE SENT IN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MATRXNEUR SCRDRVR BLD HEX CPL/SLFRET/MD THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18979367 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 8 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836552 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 6 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836547 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 7 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836545 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 4 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836544 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 5 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836543 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 1 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836541 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 3 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836534 ↗MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THERE WERE EIGHT SCREWDRIVER BLADES THAT WERE NOT HOLDING THE SCREWS PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 2 OF 8 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18836531 ↗MalfunctionJun 6, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE MATRIX NEURO SCREWDRIVER SHAFT DROPPED SCREWS IN THE PROCEDURE. A NEW SET OF SCREWS AND AN ADDITIONAL INSTRUMENT SET WAS OPENED. THERE WAS A PROCEDURAL DELAY OF UNKNOWN LENGTH DUE TO THE EVENT. ONE SCREWDRIVER WAS INVOLVED IN THE INCIDENT, BUT IT WAS NOTED THAT A TOTAL OF FIVE WERE WORN OUT ON THE SET. THEY HAVE BECOME BLUNTED WITH USE AND AGE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 4 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17074846 ↗MalfunctionJun 6, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE MATRIX NEURO SCREWDRIVER SHAFT DROPPED SCREWS IN THE PROCEDURE. A NEW SET OF SCREWS AND AN ADDITIONAL INSTRUMENT SET WAS OPENED. THERE WAS A PROCEDURAL DELAY OF UNKNOWN LENGTH DUE TO THE EVENT. ONE SCREWDRIVER WAS INVOLVED IN THE INCIDENT, BUT IT WAS NOTED THAT A TOTAL OF FIVE WERE WORN OUT ON THE SET. THEY HAVE BECOME BLUNTED WITH USE AND AGE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 5 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073506 ↗MalfunctionJun 6, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE MATRIX NEURO SCREWDRIVER SHAFT DROPPED SCREWS IN THE PROCEDURE. A NEW SET OF SCREWS AND AN ADDITIONAL INSTRUMENT SET WAS OPENED. THERE WAS A PROCEDURAL DELAY OF UNKNOWN LENGTH DUE TO THE EVENT. ONE SCREWDRIVER WAS INVOLVED IN THE INCIDENT, BUT IT WAS NOTED THAT A TOTAL OF FIVE WERE WORN OUT ON THE SET. THEY HAVE BECOME BLUNTED WITH USE AND AGE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 1 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073502 ↗MalfunctionJun 6, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE MATRIX NEURO SCREWDRIVER SHAFT DROPPED SCREWS IN THE PROCEDURE. A NEW SET OF SCREWS AND AN ADDITIONAL INSTRUMENT SET WAS OPENED. THERE WAS A PROCEDURAL DELAY OF UNKNOWN LENGTH DUE TO THE EVENT. ONE SCREWDRIVER WAS INVOLVED IN THE INCIDENT, BUT IT WAS NOTED THAT A TOTAL OF FIVE WERE WORN OUT ON THE SET. THEY HAVE BECOME BLUNTED WITH USE AND AGE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 2 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073500 ↗MalfunctionJun 6, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE MATRIX NEURO SCREWDRIVER SHAFT DROPPED SCREWS IN THE PROCEDURE. A NEW SET OF SCREWS AND AN ADDITIONAL INSTRUMENT SET WAS OPENED. THERE WAS A PROCEDURAL DELAY OF UNKNOWN LENGTH DUE TO THE EVENT. ONE SCREWDRIVER WAS INVOLVED IN THE INCIDENT, BUT IT WAS NOTED THAT A TOTAL OF FIVE WERE WORN OUT ON THE SET. THEY HAVE BECOME BLUNTED WITH USE AND AGE. THIS REPORT INVOLVES ONE MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073498 ↗MalfunctionJun 6, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON MAY 17, 2023, THAT THE HOSPITAL¿S MEDIUM SCREWDRIVER BLADES USED IN NEURO HAVE BECOME BLUNTED WITH USE AND AGE. THEY ARE NO LONGER RETAINING SCREWS AS DESIGNED. ANOTHER SET WAS USED. THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17071713 ↗MalfunctionJun 6, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON MAY 17, 2023, THAT THE HOSPITAL¿S MEDIUM SCREWDRIVER BLADES USED IN NEURO HAVE BECOME BLUNTED WITH USE AND AGE. THEY ARE NO LONGER RETAINING SCREWS AS DESIGNED. ANOTHER SET WAS USED. THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17071708 ↗MalfunctionJun 6, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE HOSPITAL¿S MEDIUM SCREWDRIVER BLADES USED IN NEURO HAVE BECOME BLUNTED WITH USE AND AGE. THEY ARE NO LONGER RETAINING SCREWS AS DESIGNED. ANOTHER SET WAS USED. THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17071705 ↗
Other SCREWDRIVER devices
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- 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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