NA 03.632.052Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705034719085), received between May 16, 2017 and Mar 30, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (16 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION FOR A LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2026. DURING PLACEMENT OF THE TRANSVERSE, FINAL CONCLUSION COULD NOT BE DONE SMOOTHLY WHEN THE SURGEON TRIED TO WITH THE SHAFT IN QUESTION. SO, IT WAS DONE WITH ANOTHER SHAFT. UPON POST-OPERATIVE EXAMINATION, THE TIP OF THE SHAFT APPEARED TO BE WORN DOWN, POSSIBLY DUE TO METAL FATIGUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728698 ↗
• MalfunctionOct 15, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN USING THE MATRIX X LINK TIGHTENING SHAFT, THE TIP SLIPS IN THE SCREW AND IS VISIBLY WORN, MAKING TIGHTENING OF THE CROSS LINK INCREDIBLY DIFFICULT. A SECOND TIGHTENER WAS AVAILABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278455 ↗
• MalfunctionMar 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE HAS WORN OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553825 ↗
• MalfunctionMar 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE HAS WORN OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553811 ↗
• MalfunctionMar 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE HAS WORN OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553806 ↗
• MalfunctionFeb 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST CASE THE INSTRUMENT INSPECTION FOUND SCREWDRIVERS WERE STRIPPING AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCK STARDRV SCRDRVR SHAFT T15-SHORT QC THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691163 ↗
• MalfunctionFeb 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST CASE THE INSTRUMENT INSPECTION FOUND SCREWDRIVERS WERE STRIPPING AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCK STARDRV SHAFT T15-SHORT QC THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691142 ↗
• MalfunctionFeb 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST CASE THE INSTRUMENT INSPECTION FOUND SCREWDRIVERS WERE STRIPPING AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCK STARDRV SCRDRVR SHAFT T15-SHORT QC THIS IS REPORT 2 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691101 ↗
• MalfunctionFeb 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST CASE THE INSTRUMENT INSPECTION FOUND SCREWDRIVERS WERE STRIPPING AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCK STARDRV SCRDRVR SHAFT T15-SHORT QC THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691043 ↗
• MalfunctionJan 30, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT 2 DRIVER TIPS WERE STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SCRDRIVER T15 SHORT F/MATRIX. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608919 ↗
• MalfunctionJan 30, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT 2 DRIVER TIPS WERE STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SCRDRIVER T15 SHORT F/MATRIX THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608890 ↗
• MalfunctionJan 24, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THE SCREW DRIVER GROOVES BURRED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) LOCK STARDRV SCRDRVR SHAFT T15-SHORT QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570935 ↗
• MalfunctionOct 17, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING L4-5 TLIF CASE, THE SURGEON USED THE T15 WITH TORQUE HANDLE TO REMOVE CROSS-CONNECTOR TO REPOSITION A SCREW IN (LEFT) L4. THE TIP OF THE T15 WAS BENT/WORN SO ANOTHER T15 FROM ANOTHER TRAY WAS OPENED TO CONTINUE. THE SCREW WAS REPOSITIONED AND PATIENT WAS CLOSED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616311 ↗
• MalfunctionAug 10, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT THE DRIVER WASN'T GRIPPING AS WELL AS USUAL INTO THE SCREW WHEN TIGHTENING A CROSSLINK. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) SCRDRIVER T15 SHORT F/MATRIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198765 ↗
• MalfunctionJan 12, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE TIP OF THE SCREWDRIVER WAS WORN OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO 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 13236059 ↗
• MalfunctionSep 22, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020, THE DRIVER SHAFT HAD ITS TIP STRIPPED WHILE IN USE. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10568258 ↗
• MalfunctionApr 29, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN L5-S1 PLIF PROCEDURE ON (B)(6) 2020, IT WAS DISCOVERED THAT A MATRIX CROSSLINK DRIVER WAS STRIPPED. THE SURGEON USED A MALLET TO SECURE A STRONGER FIT OF THE DRIVER INTO THE CROSSLINK HEX. PROCURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF TWO (2) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A LOCKING STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009060 ↗
• InjuryOct 23, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  UPDATED EVENT DESCRIPTION: THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE SIX (6) MATRIX PEDICLE SCREWS. TWO (2) SCREWS WERE REMOVED. IT WAS NOT ATTEMPTED TO REMOVE TWO (2) OTHER SCREWS DUE TO INABILITY TO REMOVE THE TWO SCREWS NEXT TO THEM. FOUR (4) SCREWS REMAINED IN THE PATIENT. THE SCREWDRIVER DID NOT RETAIN ITS SHAPE FOLLOWING THE REMOVAL OF THE FIRST TWO (2) SCREWS. IT IS UNCLEAR AT WHAT POINT DAMAGE OCCURRED TO THE SCREWDRIVER. CONCOMITANT DEVICES REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 4).

  Patient problems: No Code Available

  MAUDE report 9226855 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE SCREWDRIVER WAS FOUND IS USED UP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE ARE NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205097 ↗
• MalfunctionAug 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN L2-5 POSTERIOR SPINAL FUSION WITH BILATERAL RODS AND SCREWS. THE SURGEON NEEDED TO REMOVE A SCREW FROM AN UNKNOWN COMPANY. WHILE TRYING TO REMOVE THE SCREW, THE SURGEON ASKED FOR ONE (1) SCREWDRIVER SHAFT STAR DRIVE FOR MATRIX. THE SALES CONSULTANT INFORMED THE DOCTOR THAT THE SCREWDRIVER SHAFT STAR DRIVE FOR MATRIX WAS NOT A REMOVAL DRIVER, BUT THE SURGEON TRIED ANYWAY. THE SURGEON SUCCESSFULLY REMOVED ONE (1) SCREW AND WHILE TRYING TO REMOVE THE SECOND SCREW, THE TIP OF THE SCREWDRIVER SHAFT STAR DRIVE FOR MATRIX BROKE OFF. THE TIP WAS RETRIEVED EASILY AND THE SCREW WAS REMOVED USING THE "HELICOPTER" TECHNIQUE. LATER IN THE SURGERY, AFTER THE SURGEON IMPLANTED THE MATRIX SCREW, THE SALES CONSULTANT NOTICED THE TIP OF THE HOLDING SLEEVE FOR MATRIX BROKE. THE HOLDING SLEEVE FOR MATRIX WAS REMOVED FROM THE STERILE FIELD AND A NEW ONE WAS USED. ON THE NEXT SCREW, THE SALES CONSULTANT NOTICED THAT THE SAME THING WAS STARTING TO HAPPEN WITH THE HOLDING SLEEVE FOR MATRIX. A THIRD HOLDING SLEEVE FOR MATRIX WAS AVAILABLE AND WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860847 ↗
• MalfunctionMar 21, 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, DURING AN L3- S1 POSTERIOR SPINAL FUSION TO STABILIZE THE SPINE, THE SCREWDRIVER SHAFT STARDRIVE FOR MATRIX WAS DISCOVERED STRIPPED PRIOR TO USE AND WAS UNUSABLE. THE PROCEDURE WAS COMPLETED USING A TRAUMA T15 SCREWDRIVER. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SCREWDRIVER SHAFT STARDRIVE FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441067 ↗
• MalfunctionAug 10, 2018Material Twisted/Bent; Material Twisted/Bent

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772554 ↗
• MalfunctionJul 17, 2018Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PRIOR TO A POSTERIOR SPINAL FUSION PROCEDURE, THE TIP OF THE LOCKING STARDRIVE SCREWDRIVER SHAFT WAS LOOKING WORN. THE DEVICE WAS NOT USED ON A PATIENT AS DEVICE WAS NOT NEEDED. THERE WAS NO PATIENT INVOLVEMENT AND SURGICAL PROCEDURE. THIS REPORT IS FOR ONE (1) LOCKING STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693917 ↗
• MalfunctionFeb 14, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A POSTERIOR INSTRUMENTED FUSION AT L2-S1 ON (B)(6) 2015. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REVISION DUE TO RADICULOPATHY, NARROWING FORAMEN, AND REDUCTION OF DISC HEIGHT. DURING THE REVISION PROCEDURE, SURGEON WAS ATTEMPTING TO TORQUE OFF THE MATRIX CROSSLINK INNER SET SCREW BUT HAD DIFFICULTY AS THE TIP OF THE LOCKING STARDRIVER SCREWDRIVER SHAFT T15 WAS WORN, STRIPPED, AND HAD SHEARED OFF. SURGEON WAS UNABLE TO TORQUE OFF ONE (1) SET SCREW. SURGERY WAS DELAYED APPROXIMATELY 10 MINUTES. NO ADVERSE EFFECT TO PATIENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270772 ↗
• MalfunctionMay 19, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A LUMBAR CANAL STENOSIS (LCS) STABILIZING PROCEDURE AT L4-L5 ON (B)(6) 2017, AS SURGEON WAS FIXING A SCREW, THE TIP OF THE LOCKING STARDRIVER SCREWDRIVER SHAFT WAS STRIPPED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT MEDICAL PRODUCTS: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING STARDRIVER SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578129 ↗