MatrixMANDIBLE 03.503.071Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10887587011875), received between Oct 8, 2018 and Jun 27, 2025 — classified as 1 injury, 64 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (41 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE SCREWDRIVER PART DID NOT HOLD THE SCREW; A FRACTURE IN THE CENTER OF THE EDGES IS EVIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347316 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE OF THE SCREWDRIVER SHAFTS DID BREAKDOWN DURING PROCEDURE. ALL PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21895740 ↗
• 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 21733535 ↗
• MalfunctionMar 28, 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. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724495 ↗
• 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 21599775 ↗
• 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 21599771 ↗
• 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 21599413 ↗
• 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 21597099 ↗
• 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 21229953 ↗
• 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 20827837 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, SCREWDRIVER BLADES (SELF RETAINING) WERE NOT HOLDING THE SCREWS PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192564 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, SCREWDRIVER BLADES (SELF RETAINING) WERE NOT HOLDING THE SCREWS PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192212 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON JANUARY 10 2024, THE SCREW DRIVER WAS STUCK TO THE HANDLE. THE PRODUCT DAMAGE DOCUMENTED HAD BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT MATMAND MED SELF-HOLDING THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580238 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A CASE, THE SURGEON COMPLAINED ABOUT SOME BROKEN INSTRUMENTS, TO BE REPLACED. THERE WAS NO OTHER INFORMATION PROVIDED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-MD. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496138 ↗
• MalfunctionJan 11, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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-MEDIUM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495107 ↗
• 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 18491629 ↗
• 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-MEDIUM. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491626 ↗
• MalfunctionOct 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS IDENTIFIED THAT BOTH INSTRUMENTS GOT STUCK TOGETHER. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855034 ↗
• 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 MATRIX COMBO SET. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MATRIX MANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM THIS IS REPORT 3 OF 4 FOR COMPLAINT PC- B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811170 ↗
• 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-MEDIUM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811116 ↗
• 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-MEDIUM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17776893 ↗
• 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-MEDIUM. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17776889 ↗
• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCREWDRIVER BLADES IN QUESTION WERE NOT STAYING ENGAGED WITH THE 8MM 2.0 MANDIBLE SCREWS AND WOULD STRIP WHEN ATTEMPTING TO SEAT THE SCREWS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17767436 ↗
• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCREWDRIVER BLADES IN QUESTION WERE NOT STAYING ENGAGED WITH THE 8MM 2.0 MANDIBLE SCREWS AND WOULD STRIP WHEN ATTEMPTING TO SEAT THE SCREWS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17767429 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2023. DURING SURGERY, THE SCREWDRIVER SHAFT COULD NOT HOLD A SCREW. THE SAME SCREWDRIVER SHAFT IN DIFFERENT LENGTHS IN THE SET WAS USED INSTEAD OF THE SCREWDRIVER SHAFT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR (1) MATRIX MANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985800 ↗