MatrixMANDIBLE 03.503.072Recalls & reported problems
Synthes GmbH · MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes MatrixMandible long self-retaining screwdriver blade is used during surgery to hold and drive bone screws. The 44 reports mostly describe the blade wearing out or twisting so it loses grip on screws, plus some breakage and blades not fitting other devices. No deaths and one injury are reported. There are no recalls naming 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
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10887587011882), received between Mar 19, 2019 and Oct 21, 2025 — classified as 1 injury, 43 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (22 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/Bent22
- Device-Device Incompatibility14
- Break9
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information4
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT TWO (2) SCREWDRIVER BLADES ARE NOT HOLDING THE SCREWS ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351252 ↗MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT TWO (2) SCREWDRIVER BLADES ARE NOT HOLDING THE SCREWS ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351251 ↗MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING SURGERY, THE SELF-FASTENING LONG SCREWDRIVER PART HAD THE TIP VERY WORN AND DID NOT HAVE GOOD GRIP OF THE SCREWS. THERE WAS NO DISCOMFORT OF THE SPECIALIST, AND THE SURGERY ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456593 ↗MalfunctionMar 31, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21733542 ↗MalfunctionMar 31, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21733539 ↗MalfunctionMar 31, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21733538 ↗MalfunctionMar 31, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP (REDACTED). NO PATIENT INVOLVEMENT AND NO LOT NUMBER AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729703 ↗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 21599423 ↗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 21599422 ↗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 21599421 ↗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 21597096 ↗MalfunctionJan 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING SURGERY, THE SCREWDRIVERS DO NOT HOLD THE SCREWS AND THEY FALL OUT EASILY. THESE SCREWDRIVERS WERE LONG, SO AT THE SPECIALIST'S REQUEST, THE SHORT SCREWDRIVERS THAT ARE ALSO INCLUDED IN THE EQUIPMENT WERE USED THUS ACHIEVING A SUCCESSFUL COMPLETION OF THE SURGERY, WITHOUT AFFECTING THE PATIENT, WITHOUT DISCOMFORT TO THE SPECIALIST AND WITHOUT ALTERATIONS IN SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229949 ↗MalfunctionDec 2, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2024. THE SCREWDRIVER WOULD NOT HOLD THE SCREW. IT WAS IDENTIFIED THAT THE TIP OF IT IS WORN. OTHER PIECE WAS ASSEMBLED AND IT HAD THE SAME ISSUE. THE PIECES WERE CHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20826529 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL ITEMS WERE BROKEN AND FAULTY FROM OVERUSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4). 03.503.203 × 8 03.503.072 X2 (B)(4) CAPTURES 03.503.072 X 2 311.023 × 2 397.211 X2 306.757 X3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19726170 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL ITEMS WERE BROKEN AND FAULTY FROM OVERUSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMID FACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4). 03.503.203 × 8, 03.503.072 X2. (B)(4) CAPTURES: 03.503.072 X 2, 311.023 × 2, 397.211 X2, 306.757 X3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19726126 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES ARE BROKEN/FAULTY FROM OVERUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCREWDRIVER BLADE SELF RETAINING-LONG. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4). THIS (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721124 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES ARE BROKEN/FAULTY FROM OVERUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4). THIS (B)(4) CAPTURES ADDITIONAL REPORTED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721122 ↗MalfunctionJan 11, 2024Break; Break
IT WAS FURTHER REPORTED THAT NO BROKEN FRAGMENTS RETAINED IN THE PATIENT AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18495616 ↗MalfunctionJan 11, 2024Break; Break
NO FRAGMENTS WERE GENERATED, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491643 ↗MalfunctionJan 11, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE, THE SURGEON COMPLAINT ABOUT SOME BROKEN INSTRUMENTS THAT NEEDED TO BE REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 8 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491632 ↗MalfunctionJan 11, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE, THE SURGEON COMPLAINT ABOUT SOME BROKEN INSTRUMENTS THAT NEEDED TO BE REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491630 ↗MalfunctionSep 25, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2023, THE SURGEON WAS HAVING ISSUES WITH THE SCREWDRIVER SHAFT NOT STAYING ENGAGED WITH THE SCREWS IN THE MANDIBLE MODULE OF THE MATRIXCOMBO SET. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17811213 ↗MalfunctionSep 25, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2023, THE SURGEON WAS HAVING ISSUES WITH THE SCREWDRIVER SHAFT NOT STAYING ENGAGED WITH THE SCREWS IN THE MANDIBLE MODULE OF THE MATRIXCOMBO SET. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17811153 ↗MalfunctionSep 19, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON HAD A PROBLEM WITH THE SCREWDRIVER SHAFT NOT STAYING ENGAGED WITH THE SCREW FROM THE MANDIBLE MODULE IN THE MATRIXCOMBO SET. SURGEON ALSO COMPLAINED ABOUT THE HEAD OF THE SCREWS BEING STRIPPED AND NOT GETTING SATISFACTION ABOUT THE SCREWS BEING TIGHT ENOUGH. NO SURGICAL DELAY WAS REPORTED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17776895 ↗MalfunctionSep 19, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON HAD A PROBLEM WITH THE SCREWDRIVER SHAFT NOT STAYING ENGAGED WITH THE SCREW FROM THE MANDIBLE MODULE IN THE MATRIXCOMBO SET. SURGEON ALSO COMPLAINED ABOUT THE HEAD OF THE SCREWS BEING STRIPPED AND NOT GETTING SATISFACTION ABOUT THE SCREWS BEING TIGHT ENOUGH. NO SURGICAL DELAY WAS REPORTED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17776892 ↗
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.
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