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Matrix 03.632.072Recalls & reported problems

Synthes GmbH · T25 STARDRIVE SHAFT F/MATRIX LONG · Class 1

Quick summary

This Synthes Matrix screwdriver is a surgical tool used to drive screws during spine procedures. The 83 reports mostly describe driver tips wearing down, bending, stripping or breaking, often noticed during post-op inspection with no patient involvement. There are no deaths, 2 injuries, and no recalls name this device. Reports rose from 3 to 8 in the last 12 months.

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
83
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10705034719160), received between Jan 10, 2017 and Jan 9, 2026 — classified as 2 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (37 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 4 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 5 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Integrity Problem37
  • Material Twisted/Bent20
  • Dull, Blunt15
  • Break5
  • Compatibility Problem3
  • Bent2
  • Device-Device Incompatibility2
  • Material Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions35
  • No Consequences Or Impact To Patient20
  • No Patient Involvement14
  • No Known Impact Or Consequence To Patient9
  • No Code Available5
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 9, 2026Material Integrity Problem

    IT WAS REPORTED ON (B)(6) 2025, THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24018733 ↗
  • MalfunctionJan 9, 2026Material Integrity Problem

    IT WAS REPORTED ON (B)(6) 2025 THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24018731 ↗
  • MalfunctionJan 9, 2026Material Integrity Problem

    IT WAS REPORTED ON (B)(6) 2025 THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24018729 ↗
  • MalfunctionJan 7, 2026Material Integrity Problem

    IT WAS REPORTED ON DECEMBER 15, 2025 THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23988612 ↗
  • MalfunctionJan 5, 2026Material Integrity Problem

    IT WAS REPORTED THAT WHEN USING MATRIX DEGEN SPINE SYSTEM SCREWDRIVER WAS NOT ENGAGING WITH SCREW. THE SHAFT END OF THE SCREWDRIVER APPEARED WORN, INDICATING LIKELY WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23959014 ↗
  • MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2025 UPON POST OPERATIVE INSPECTION THE SCREWDRIVERS WERE NOTED TO BE STRIPPED AND BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23621721 ↗
  • MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2025 UPON POST OPERATIVE INSPECTION THE SCREWDRIVERS WERE NOTED TO BE STRIPPED AND BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23621715 ↗
  • MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2025 UPON POST OPERATIVE INSPECTION THE SCREWDRIVERS WERE NOTED TO BE STRIPPED AND BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23621701 ↗
  • MalfunctionAug 19, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2025, THE THREE ITEMS WERE FOUND TO BE BROKEN/WORN BEYOND REPAIR DURING POST OP INSPECTION. THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22839468 ↗
  • MalfunctionAug 19, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6), 2025, THE THREE ITEMS WERE FOUND TO BE BROKEN/WORN BEYOND REPAIR DURING POST OP INSPECTION. THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22839386 ↗
  • MalfunctionAug 19, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2025, THE THREE ITEMS WERE FOUND TO BE BROKEN/WORN BEYOND REPAIR DURING POST OP INSPECTION. THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22839333 ↗
  • MalfunctionOct 16, 2024Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING POST OP INSPECTION, USER FOUND SEVERAL WORN OUT INSTRUMENTS IN NEED OF REPLACEMENT. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20460885 ↗
  • MalfunctionOct 15, 2024Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING POST OP INSPECTION, USER FOUND SEVERAL WORN OUT INSTRUMENTS IN NEED OF REPLACEMENT. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20458307 ↗
  • MalfunctionOct 15, 2024Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING POST OP INSPECTION, USER FOUND SEVERAL WORN OUT INSTRUMENTS IN NEED OF REPLACEMENT. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20458305 ↗
  • MalfunctionOct 15, 2024Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING POST OP INSPECTION, USER FOUND SEVERAL WORN OUT INSTRUMENTS IN NEED OF REPLACEMENT. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20458303 ↗
  • MalfunctionJun 12, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TIP OF THE SCREWDRIVER SHAFT WAS WORN AND IT WAS SLIPPING ON MATRIX. ALSO MATRIX TORQUE HANDLE FAILED HOSPITAL TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX LONG THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19523990 ↗
  • MalfunctionJun 7, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2024 WHEN FINAL TIGHTENING THE SET SCREWS THE STAR DRIVE WAS STRIPPED AND WOULD NOT FINAL TIGHTEN SET SCREWS, IT KEPT BOUNCING OUT THE SCREW. ANOTHER STAR DRIVE AVAILABLE ON THE SET WAS USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19485085 ↗
  • MalfunctionAug 2, 2023Material Integrity Problem; Material Integrity Problem

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE INSTRUMENTS WERE DAMAGED FROM REPEATED USE IN THEATRES. THE TIP OF THE SCREWDRIVER SHAFTS ARE BOTH WORN AND SLIPPING WHEN FINAL TIGHTENING. THIS REPORT INVOLVES ONE (1) T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17446659 ↗
  • MalfunctionAug 2, 2023Material Integrity Problem; Material Integrity Problem

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE INSTRUMENTS WERE DAMAGED FROM REPEATED USE IN THEATRES. THE TIP OF THE SCREWDRIVER SHAFTS ARE BOTH WORN AND SLIPPING WHEN FINAL TIGHTENING. THIS REPORT INVOLVES ONE (1) T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17443461 ↗
  • MalfunctionApr 25, 2023Material Integrity Problem; Material Integrity Problem

    THERE WERE NO ALLEGATIONS AGAINST THE SCREW SET; THEY WERE STILL ABLE TO BE FINAL TIGHTENED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16811164 ↗
  • MalfunctionMar 31, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6), THE SURGEON KEPT STRIPPING DRIVERS TO FINAL TIGHTEN THE CONNECTOR DURING SURGERY. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16655907 ↗
  • MalfunctionMar 31, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON KEPT STRIPPING DRIVERS TO FINAL TIGHTEN THE CONNECTOR DURING SURGERY. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16655809 ↗
  • MalfunctionMar 31, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON KEPT STRIPPING DRIVERS TO FINAL TIGHTEN THE CONNECTOR DURING SURGERY. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16655808 ↗
  • MalfunctionMar 31, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON KEPT STRIPPING DRIVERS TO FINAL TIGHTEN THE CONNECTOR DURING SURGERY. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16655807 ↗
  • MalfunctionOct 28, 2022Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVERS BROKE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T25 STARDRIVE SHAFT F/MATRIX LONG. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15691684 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.