MatrixMANDIBLE 03.503.066Recalls & reported problems
Synthes GmbH · MATRIXMANDIBLE SCRWDRVR BLADE SHORT/NON SELF-RETAINING · Class 1
All models of MatrixMANDIBLE (79)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587011820), received between Apr 24, 2023 and Nov 1, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (1 report).
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 Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Material Deformation; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A REMOVAL SURGERY PERFORMED ON (B)(6), 2023, THE SURGEON ATTEMPTED TO EXTRACT THE MATRIX RIB SCREW WITH THE SCREWDRIVER AND SLEEVE, BUT THE SCREW WAS TOO TIGHT TO BE EXTRACTED, PARTLY BECAUSE IT HAD BEEN SOME TIME SINCE IT WAS INSERTED. THE SURGEON TRIED SEVERAL SCREWDRIVERS AND SLEEVES. THE SURGEON ALSO FELT THAT THOSE INSTRUMENTS GOT BENT. THE SCREW WAS EVENTUALLY EXTRACTED BY USING A CARBIDE DRILL, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A LESS THAN 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. UPON MANUFACTURER INVESTIGATION OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT THE RETURNED SCREWDRIVER SHAFT WAS BROKEN. THIS REPORT INVOLVES ONE MATRIXMANDIBLE SCRWDRVR BLADE SHORT/NON SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18048503 ↗MalfunctionApr 24, 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, IT WAS NOTED THAT THERE WAS WEAR AND TEAR OF THE ITEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE SCRWDRVR BLADE SHORT/NON SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16795217 ↗
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 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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