SYNFIX Evolution 03.835.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034816234), received between Aug 17, 2018 and May 5, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT WHEN INSPECTING INSTRUMENTS RECEIVED THROUGH DECONTAMINATION, PRIOR TO STERILIZATION - THE SYNFIX EVOLUTION AWLS AND 2 SCREWDRIVER SHAFTS WERE OBSERVED TO BE WORN. THE AWL WAS NO LONGER SHARP AND THE DRIVER TIPS WERE BEGINNING TO STRIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082691 ↗
• MalfunctionJun 5, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT THE DRIVER ON THE SET IS NOT RETAINING ITS POSITION AT ALL AND IS MAKING PLACEMENT OF THE SCREWS VERY DIFFICULT. SURGERY COMPLETED WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150621 ↗
• MalfunctionJan 27, 2025Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE DOING A 3 LEVEL ALIF CASE, AT THE SECOND LEVEL, L4-5, SURGEON WAS IMPLANTING A SYNFIX EVO CAGE. WHEN INSERTING THE THIRD SCREW INTO THE IMPLANT, THE DRIVER BECAME HARD TO TURN NEAR THE END OF FINAL TIGHTENING THE SCREW INTO THE INTEGRATED PLATE AND TRYING TO GET THE DRIVER TO ACHIEVE THE DESIRED TORQUE LEVEL. AFTER APPLYING ADDITIONAL FORCE, THE DRIVER HANDLE TORQUED OUT BUT IT WAS OBSERVED THAT THE TIP OF THE DRIVER SHAFT HAD SHEARED OFF INSIDE OF THE HEAD OF THE SCREW. THE SCRUB TECHNICIAN SWITCHED OUT THE U-JOINT SCREWDRIVER FOR THE STRAIGHT DRIVER SHAFT AND SURGEON INSERTED THE FOURTH AND FINAL SCREW WITH IT, BUT DID NOT FINAL-TIGHTEN IT, WHILE REP WENT DOWN TO SPD TO GRAB ANOTHER INSTRUMENT TRAY. THE BACK UP INSTRUMENT TRAY WAS OPENED BY THE CIRCULATING NURSE, THE WRAP INSPECTED FOR STERILITY AND CLEARED TO ENTER THE STERILE FIELD AND BACK TABLE. THE SCRUB TECHNICIAN ASSEMBLED THE TORQUE HANDLE AND U-JOINT SCREWDRIVER FROM THE SECOND INSTRUMENT TRAY AND THE FOURTH SCREW WAS FINAL-TIGHTENED WITHOUT ISSUE. THE AIMING GUIDE WAS REMOVED FROM THE IMPLANT A FEW DIFFERENT ATTEMPTS WERE MADE BY SURGEON TO REMOVE THE TIP OF THE BROKEN DRIV

  Patient problems: Foreign Body In Patient

  MAUDE report 21244715 ↗
• 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 W/O THREAD LOCK SLEEVE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854709 ↗
• InjuryJun 27, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE SCREW RECESS. THE ADDITIONAL SCREWDRIVER IN THE SET WAS UTILIZED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND THEY WERE NOT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. YES, THERE WAS PATIENT INVOLVEMENT AS IT HAPPENED INTRAOPERATIVELY. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14831807 ↗
• MalfunctionSep 16, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE THAT SCREWDRIVER WOULD NOT HOLD THE SCREW PROPERLY AND THE HANDLE WAS NOT PERFORMING PROPERLY. A NEW SET WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREWDRIVER W/O THREAD LOCK SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481085 ↗
• MalfunctionMay 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SYNFIX EVOLUTION SET, STANDARD INSTRUMENTS-EVAL WAS USED IN SURGERY ON (B)(6) 2019. ON (B)(6) 2019, FIELD STOCKING LOCATION (FSL) WAS INFORMED THAT THE SET WAS READY FOR PICK UP ON THAT DATE. THE SCREW LOADING STATION FOR SYNFIX EVOLUTION, SYNFIX EVOLUTION AWL/WITHOUT SLEEVE, HANDLE WITH QUICK COUPLING-SMALL, AND TWO (2) SYNFIX EVOLUTION SCREWDRIVER WITHOUT THREAD LOCK SLEEVE WAS PICKED UP BY OWENS AND MINORS. UPON INSPECTION, QWENS AND MINORS FOUND BLOOD ON THE PARTS OF THE SET AND REPORTED TO FSL. IT WAS FURTHER CLARIFIED THAT THESE ARE INSTRUMENT TRAYS USED BY FSAL AND THE TRAYS WERE DISCOVERED TO BE "SOILED". THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION SCREWDRIVER WITHOUT THREAD LOCK SLEEVE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8591928 ↗
• MalfunctionMay 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SYNFIX EVOLUTION SET, STANDARD INSTRUMENTS-EVAL WAS USED IN SURGERY ON (B)(6) 2019. ON (B)(6) 2019, FIELD STOCKING LOCATION (FSL) WAS INFORMED THAT THE SET WAS READY FOR PICK UP ON THAT DATE. THE SCREW LOADING STATION FOR SYNFIX EVOLUTION, SYNFIX EVOLUTION AWL/WITHOUT SLEEVE, HANDLE WITH QUICK COUPLING-SMALL, AND TWO (2) SYNFIX EVOLUTION SCREWDRIVER WITHOUT THREAD LOCK SLEEVE WAS PICKED UP BY (B)(4). UPON INSPECTION, (B)(4) FOUND BLOOD ON THE PARTS OF THE SET AND REPORTED TO FSL. IT WAS FURTHER CLARIFIED THAT THESE ARE INSTRUMENT TRAYS USED BY FSAL AND THE TRAYS WERE DISCOVERED TO BE "SOILED". THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION SCREWDRIVER WITHOUT THREAD LOCK SLEEVE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8591926 ↗
• MalfunctionMar 29, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION (ALIF) L5-S1. DURING THE SURGERY, THE SURGEON WAS SCREWING IN THE SCREWS AND THE TIP OF THE SCREWDRIVER BROKE OFF. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN SCREWS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREWDRIVER W/O THREAD LOCK SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465091 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED THAT DURING SYNFIX EVOLUTION REVISION MULTIPLE SCREWDRIVERS BROKE OFF OR DEFORMED DURING SCREW REMOVAL. IMPLANT WAS SUCCESSFULLY REMOVED, NO PATIENT HARM. THIS IS ALL INFORMATION WE HAVE SO FAR. THE BREAKAGE OCCURRED WHILE TRYING TO REMOVE THE SCREWS. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795180 ↗