MatrixMANDIBLE 03.503.073Recalls & reported problems
Synthes GmbH · MATRIXMANDIBLE/THORAX SCRWDRVR FIXED HANDLE/SELF-RETAINING · Class 1
All models of MatrixMANDIBLE (79)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587011899), received between Aug 21, 2017 and Aug 5, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED INTRAOPERATIVELY IT WAS NOTED THE CRUCIFORM TIP WAS NOT PRESS FITTING THE SCREWS PROPERLY CAUSING THE SCREW TO FALL OFF THE SCREWDRIVER WHEN INSERTED. UPON INSPECTION IT APPEARS THE TIP WAS DAMAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910790 ↗MalfunctionSep 2, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A MANDIBLE RECONSTRUCTION WITH A FIBULA FREE FLAP AND DENTAL IMPLANT PLACEMENT. IT WAS NOTED THAT THE SCREWDRIVER WAS NOT PICKING UP SCREWS. THEY USED DIFFERENT SCREWDRIVER FOR ANOTHER TRAY. THERE WAS A FIVE-MINUTE SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12416382 ↗MalfunctionAug 21, 2017Break; Break
IT WAS REPORTED THAT THE TIP OF A MATRIXMANDIBLE SCREWDRIVER IS BROKEN. THIS WAS DISCOVERED WHILE DOING YEARLY INVENTORY OF THE SETS. THERE WAS NO PATIENT INVOLVEMENT.THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 6808499 ↗
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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