Matrix 03.632.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034718705), received between Oct 9, 2017 and Sep 3, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (5 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025. WHILE USING THE SCREWDRIVER TO REMOVE THE MATRIX SCREW, THE TIP OF THE SCREWDRIVER BROKE. THE SCREW WAS SUCCESSFULLY REMOVED USING A DIFFERENT SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956755 ↗
• MalfunctionOct 29, 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 SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694855 ↗
• MalfunctionFeb 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, 2 MATRIX SPINE SCREWDRIVER WITH A STRAIGHT HANDLE WERE STRIPPED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366669 ↗
• MalfunctionFeb 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, TWO (2) MATRIX SPINE SCREWDRIVER WITH A STRAIGHT HANDLE WERE STRIPPED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366657 ↗
• MalfunctionNov 10, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INSTRUMENT ROOM TECHNICIAN WAS ASSESSING SCREWDRIVERS PRIOR TO STERILIZATION AND IT WAS NOTED THAT THE STAR DESIGN OF TIP OF DRIVER WAS ROUNDED. THIS REPORT IS FOR ONE (1) SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10816967 ↗
• MalfunctionSep 11, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MATRIX MIS COMBINED WITH A REGULAR MATRIX CASE ON (B)(6) 2020, ISSUES OCCURRED FOR INSERTING THE CAPS (WHERE ALL OF THE SHAFT AND SPORTS GRIP SHAFT WERE NO LONGER HOLDING THE SET SCREW) AS THE DISTAL END TIP WAS DAMAGED/ SLIGHTLY STRIPPED. ALSO, DURING THE FINAL TIGHTENING, THE CANNULATED AND REGULAR LONG SHAFT STRIPPED AT THE DISTAL END TIP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SPORT GRIP T25 STARDRIVE SHAFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521016 ↗
• MalfunctionJan 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF SCREWDRIVER STARDRIVE WITH SHAFT HANDLE FOR MATRIX WAS BROKEN. IT IS UNKNOWN IF THERE WAS PROCEDURE INVOLVEMENT. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9542516 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT LUMBAR FUSION PROCEDURE, THE STRAIGHT TIP T25 SCREW DRIVER WAS BROKEN AND THE SECOND T25 STARDRIVE WAS ALSO BROKEN WHILE THE DOCTOR WAS TRYING TO LOOSEN THE UNKNOWN SET SCREW. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370157 ↗
• MalfunctionFeb 25, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS PERFORMING A POSTERIOR SPINAL FUSION TO A PATIENT. GIVEN THAT THE PATIENT HAD A VERY HARD BONE, THE TWO (2) RETAINING SLEEVES, THREE (3) SCREWDRIVER SHAFTS AND A SCREWDRIVER WITH STRAIGHT HANDLE WERE DAMAGED. THE SCREWDRIVERS WERE STRIPPED AT THE DISTAL END TIPS AND THE DISTAL END RINGS ON THE SCREWDRIVER RETAINING SLEEVES WERE DAMAGED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY . THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367009 ↗
• MalfunctionJun 26, 2018Break; Break

  (B)(6) REPORTS THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE SURGEON FOUND THAT THE STARDRIVE SCREW DRIVER TIPS HAD BECOME CHIPPED WITH WEAR OVER TIME AND IT WAS DIFFICULT TO TIGHTEN AND TWIST THE LOCKING CAPS. THERE WAS NO SURGICAL DELAY REPORTED. THERE IS NO REPORTED PATIENT CONSEQUENCE. CONCOMITANT DEVICE: LOCKING CAP (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638071 ↗
• MalfunctionMar 21, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE FOR SPONDYLOLISTHESIS AT L4-L5 ON (B)(6) 2018, THE TIP OF THE SPORT GRIP STARDRIVE SCREWDRIVER SHAFT WOULD NOT GRASP THE SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) SPORT GRIP T25 STARDRIVE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359256 ↗
• MalfunctionFeb 26, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SPORT GRIP T25 STARDRIVE SHAFT FOR MATRIX IS STRIPPED AND WILL NOT HOLD A SCREW. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) SPORT GRIP T25 STARDRIVE SHAFT FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298111 ↗
• MalfunctionDec 6, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTAL END OF TWO (2) SEPARATE SPORT GRIP T25 STARDRIVE SCREWDRIVER SHAFTS ARE SLIGHTLY STRIPPED. IT WAS ALSO NOTED THE SCREWDRIVER SLEEVE HAS A METAL RING DAMAGE, SUSPECTED TO BE DUE TO WEAR AND TEAR. ISSUE WAS DISCOVERED WHILE SCRUB NURSE WAS SETTING UP PRIOR TO SURGERY, NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7087911 ↗
• MalfunctionDec 6, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTAL END OF TWO (2) SEPARATE SPORT GRIP T25 STARDRIVE SCREWDRIVER SHAFTS ARE SLIGHTLY STRIPPED. IT WAS ALSO NOTED THE SCREWDRIVER SLEEVE HAS A METAL RING DAMAGE, SUSPECTED TO BE DUE TO WEAR AND TEAR. ISSUE WAS DISCOVERED WHILE SCRUB NURSE WAS SETTING UP PRIOR TO SURGERY, NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7087854 ↗
• MalfunctionOct 9, 2017Fitting Problem; Dull, Blunt; Fitting Problem; Dull, Blunt

  IT WAS REPORTED THAT A MATRIX STRAIGHT SCREWDRIVER MALFUNCTIONED DURING A L5-S1 FUSION ON (B)(6) 2017. THE SURGEON HAD PLACED HIS RODS AND WAS READY TO PLACE THE CAPS. WHEN THE TECHNICIAN LOADED THE LOCKING CAPS ON THE MATRIX T25 STRAIGHT SCREWDRIVER, THEY KEPT FALLING OFF. THE SCREWDRIVER WOULD NOT RETAIN THE CAPS. WE PLACED IT ON THE BACK TABLE AND USED A BACKUP SCREWDRIVER TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT PATIENT HARM. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DRIVER TIP IS WORN. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2017. CONCOMITANT DEVICES REPORTED: MATRIX LOCKING CAP WITHOUT SADDLE (PART # 09.632.099, LOT# UNKNOWN, QUANTITY # 2). THIS REPORT IS FOR ONE (1) SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-STANDARD THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931931 ↗