SYNFIX Evolution 03.835.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034814117), received between Aug 17, 2018 and Jun 21, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINE SURGERY ON JUNE 10, 2024. THE DISTAL METAL PART OF THE SCREWDRIVER WHICH ENGAGES THE SCREW HEAD BROKE OFF BELOW THE THREADED PART DURING SCREW INSERTION INTO THE CAGE. THEY MANAGED TO FISH OUT THE BROKEN PART, BUT CAN NO LONGER USE THE INSTRUMENT. SAME LIKE PRODUCT WAS USED INSTEAD. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SYNFIX® EVOLUTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586054 ↗
• MalfunctionMay 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW IN THE SYNFIX EVO AIMING DEVICE 10.5 PLUS12 BECAME STICKY AND REQUIRED MORE FORCE THAN USUAL. THE SYNFIX EVOLUTION AIMING DEVICE HOLDER CAME IN THE SET PULLED APART, AND IT COULD NOT BE PUT BACK TOGETHER AS IT WAS VERY STIFF. THE SYNFIX EVOLUTION SCREWDRIVER HAD WEAR AND TEAR ON THE DRIVER TIPS, AND FRAYED EDGES. THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYNFIX® EVOLUTION SCREWDRIVER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854710 ↗
• MalfunctionMay 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW IN THE SYNFIX EVO AIMING DEVICE 10.5 PLUS 12 BECAME STICKY AND REQUIRED MORE FORCE THAN USUAL. THE SYNFIX EVOLUTION AIMING DEVICE HOLDER CAME IN THE SET PULLED APART, AND IT COULD NOT BE PUT BACK TOGETHER AS IT WAS VERY STIFF. THE SYNFIX EVOLUTION SCREWDRIVER HAD WEAR AND TEAR ON THE DRIVER TIPS, AND FRAYED EDGES. THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYNFIX® EVOLUTION SCREWDRIVER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854708 ↗
• MalfunctionAug 24, 2021Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2021, THE SURGEON WAS TIGHTENING THE SCREWS IN TO THE IMPLANT AND THE TIP OF THE DRIVER SHEARED OFF AND REMAINED IN THE WOUND SITE. THE SURGEON SUCKED THE FRAGMENT UP WITH THE SUCKER AND RETRIEVED IT LATER FROM THE FILTER. THERE WAS NO KNOWN PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362830 ↗
• MalfunctionJul 12, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TIGHTENING END OF ONE DRIVER HAS SNAPPED OFF AND THE TIGHTENING END OF ANOTHER DRIVER WAS BADLY TWISTED. THIS WAS DISCOVERED DURING A LOAN KIT INSPECTION. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150039 ↗
• MalfunctionJul 12, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TIGHTENING END OF ONE DRIVER HAS SNAPPED OFF AND THE TIGHTENING END OF ANOTHER DRIVER WAS BADLY TWISTED. THIS WAS DISCOVERED DURING A LOAN KIT INSPECTION. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149962 ↗
• MalfunctionNov 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE SYNFIX EVOLUTION SCREWDRIVER WHICH ATTACHES THE THREAD LOCK SLEEVE TO RETAIN THE SCREW FOR INSERTION WAS NOT FUNCTIONING. THE SCREW WOULD NOT RETAIN AND KEPT FALLING OFF. SCREWDRIVER WITH A DIFFERENT THREAD LOCK SLEEVE WAS TRIED WITHOUT ANY SUCCESS. SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: THREAD LOCK SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871139 ↗
• MalfunctionMar 25, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A SYNFIX EVOLUTION SCREWDRIVER WAS NON-FUNCTIONAL. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION ON FEBRUARY 28, 2020 OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DISTAL TIP OF THE SCREWDRIVER SHAFT WAS STRIPPED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881213 ↗
• MalfunctionMar 25, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE SYNFIX EVOLUTION SCREWDRIVER WAS NON FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION ON FEBRUARY 28, 2020 OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DISTAL TIP OF THE SCREWDRIVER SHAFT AND THE INITIAL DISTAL THREAD WAS STRIPPED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881161 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE SCREWDRIVER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246909 ↗
• MalfunctionAug 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) SYNFIX EVOLUTION IMPLANT AND FOUR (4) SCREWS ON UNKNOWN DATE AT UNKNOWN LEVEL. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REVISION DUE TO INFECTION. DURING THE REMOVAL PROCEDURE, FOUR (4) SYNFIX SCREWDRIVERS BROKE OR WERE DEFORMED WHILE ATTEMPTING TO REMOVE A SCREW. NO FRAGMENTS WERE GENERATED. SURGERY WAS DELAYED APPROXIMATELY 10 MINUTES. REVISION SURGERY DUE TO INFECTION IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE INTRA-OPERATIVE ISSUES WITH THE SCREWDRIVERS. THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION SCREWDRIVER THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795114 ↗
• MalfunctionAug 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) SYNFIX EVOLUTION IMPLANT AND FOUR (4) SCREWS ON UNKNOWN DATE AT UNKNOWN LEVEL. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REVISION DUE TO INFECTION. DURING THE REMOVAL PROCEDURE, FOUR (4) SYNFIX SCREWDRIVERS BROKE OR WERE DEFORMED WHILE ATTEMPTING TO REMOVE A SCREW. NO FRAGMENTS WERE GENERATED. SURGERY WAS DELAYED APPROXIMATELY 10 MINUTES. REVISION SURGERY DUE TO INFECTION IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE INTRA-OPERATIVE ISSUES WITH THE SCREWDRIVERS. THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION SCREWDRIVER THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795093 ↗