SYNFIX Evolution 03.835.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034814056), received between Aug 17, 2018 and May 5, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 8 most recent of 8 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 25082753 ↗
• MalfunctionDec 10, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT NEWLY RECEIVED HANDLE AND SCREWDRIVER WERE DEFECTIVE. THE NEW HANDLE IS BLOCKED ON THE NEW SCREWDRIVER. IT WAS UNKNOWN IF THERE IS ANY PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SYNFIX® EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985043 ↗
• MalfunctionDec 10, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT NEWLY RECEIVED HANDLE AND SCREWDRIVER WERE DEFECTIVE. THE NEW HANDLE IS BLOCKED ON THE NEW SCREWDRIVER. IT WAS UNKNOWN IF THERE IS ANY PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS FOR (1) SYNFIX¿ EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985020 ↗
• MalfunctionSep 10, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE USING THE SYNFIX EVOLUTION SYSTEM, UPON ATTEMPTING TO PLACE THE FIRST SCREW USING THE STRAIGHT SCREWDRIVER, THE SURGICAL TECH COULD NOT ATTACH SCREW TO THE SCREWDRIVER TIP. THE SCREWDRIVER TIP DID NOT APPEAR DAMAGED BUT DID NOT FUNCTION AS INTENDED. AN ALTERNATE SCREWDRIVER FOR THE FOUR SCREWS WAS NEEDED IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN A MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515757 ↗
• MalfunctionFeb 13, 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 STRAIGHT WITHOUT SLEEVE WAS DAMAGED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE SYNFIX® EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707800 ↗
• InjuryFeb 10, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT A SYNFIX LOANER SET WAS DELIVERED TO THE CUSTOMER WITH A DEFECTIVE SCREWDRIVER. THE DRIVE WAS PREVIOUSLY MANIPULATED IN A WAY THAT NO SCREW COULD BE GRIPPED ANYMORE. THE DEVICE WAS USED FOR THE SURGERY BUT THE ATTEMPT TO USE THE AFFECTED INSTRUMENT FAILED. ANOTHER DEVICE HAD TO BE USED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT NOT AFFECTED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9687075 ↗
• MalfunctionMar 20, 2019Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  (B)(6) 2019: UPDATED EVENT DESCRIPTION: (B)(6) 2019 UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2019, THE SURGEON WAS PERFORMING A DOUBLE LEVEL OF AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) ON L4/L5 AND L5/S1. FOLLOWING INSERTION OF AN UNKNOWN SCREWS, THE SURGEON HAD SOME DIFFICULTY WITH FINAL TIGHTENING THE SCREWS USING THE TWO (2) SYNFIX EVOLUTION SCREWDRIVERS ALTERNATELY TRYING IN COMBINATION WITH THE TORQUE LIMITING HANDLE. FINALLY, THE SURGEON COULDN¿T EFFECTIVELY TIGHTENED THE TORQUE LIMITING HANDLE, SO, THE SURGEON REDUCED THE ANGLE AT THE JOINT OF THE SCREWDRIVER TO A MINIMUM (LESS THAN 40 DEGREES) TO DELIVER THE TORQUE REQUIRED FOR THE HANDLE TO TORQUE OUT. THE SURGEON SUGGESTED THAT DUE TO THE TIGHT ACCESS CHANNEL TO THE SPINE CREATED, THE SURGEON COULDN¿T ANGLE THE SCREWDRIVER IN THE REQUIRED PLANE, HENCE, THE SOFT TISSUE AND RETRACTOR WERE IN THE WAY. THEREFORE, THE SCREWS WERE LEFT AS THEY WERE HAND TIGHT WITH THE REGULAR UNKNOWN RATCHETING HANDLE. THERE WAS A 15 MINUTES SURGICAL DELAY REPORTED. THE CAGES WERE SUCCESSFULLY IMPLANTED. CONCOMITANT DEVICES REPORTED: CONCOMITANT DEVICES REPORTED: SYNFIX EVOLUTION LOCK SCREW (PART# 04.835.125.02S, LOT# UNKNOWN, QUA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8437817 ↗
• 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 STRAIGHT WITHOUT SLEEVE THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795169 ↗