SYNFIX Evolution 03.835.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034814179), received between Dec 20, 2016 and Sep 29, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Cut

  It was reported the awls in the synfix evo trays are dull. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933052 ↗
• MalfunctionSep 29, 2026Failure to Cut

  It was reported the awls in the synfix evo trays are dull. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933026 ↗
• MalfunctionSep 29, 2026Failure to Cut

  It was reported the awls in the synfix evo trays are dull. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933018 ↗
• MalfunctionSep 29, 2026Failure to Cut

  It was reported the awls in the synfix evo trays are dull. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932988 ↗
• MalfunctionSep 29, 2026Failure to Cut

  It was reported the awls in the synfix evo trays are dull. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932973 ↗
• MalfunctionSep 29, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932791 ↗
• MalfunctionMay 5, 2026Failure to Cut; Material Twisted/Bent

  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 25082861 ↗
• MalfunctionMay 5, 2026Failure to Cut; Material Twisted/Bent

  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 25082860 ↗
• MalfunctionJun 5, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET, IT WAS OBSERVED THAT THE SYNFIX EVOLUTION AWL WITHOUT SLEEVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10125397 ↗
• MalfunctionMay 18, 2020Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2020, A SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE WAS NOTED TO BE BLUNT. THE SURGEON ATTEMPTED TO USE A SECOND SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE THAT WAS OBSERVED TO BE BLUNT. THE SURGEON WAS UNSUCCESSFUL IN USING THE SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067151 ↗
• MalfunctionMay 15, 2020Dull, Blunt; Dull, Blunt

  UPDATED EVENT DESCRIPTION IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2020, A SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE WAS NOTED TO BE BLUNT. THE SURGEON ATTEMPTED TO USE A SECOND SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE THAT WAS OBSERVED TO BE BLUNT. THE SURGEON WAS UNSUCCESSFUL IN USING THE SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063499 ↗
• MalfunctionNov 4, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE SYNFIX EVOLUTION AWL WAS OBSERVED TO BE BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273358 ↗
• 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 AWL/WITHOUT SLEEVE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8591934 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WAS PERFORMED AT L4-S1 WITH SYNTHES SYNFIX EVOLUTION. THERE WERE DIFFICULTIES PLACING ONE OF THE S1 SCREWS ON THE L5-S1 LEVEL. AFTER INSERTING THE SPACER AT L5-S1, THE AWL WAS PLACED THROUGH THE AIMING DEVICE TO CANNULATE S1. IT WAS VERY DIFFICULT TO FULLY ADVANCE THE AWL INTO THE "SCLEROTIC" BONE THAT THE PATIENT HAD AT S1. THE AWL APPEARED TO BE 15MM IN LENGTH BUT THE SCREWS BEING USED WERE 25MM. THIS LEFT 10MM OF BONE NOT PREPPED FOR A SCREW. THIS WAS CONFIRMED BY VIEWING THE CT SCAN ON THE IMAGING IN THE ROOM - THE BONE WAS DENSE AND SCLEROTIC. AFTER ADVANCING THE AWL BY MALLETING AND TWISTING, A FINE TIP SCREW WAS PLACED INTO THE HOLE OF S1. AFTER ADVANCING THE SCREW ABOUT 2/3 OF THE WAY THROUGH THAT PLATE ON THE SPACER, THE SCREW WOULD NOT ADVANCE ANYMORE. THE SCREW WAS TAKEN OUT. THE SURGEON WANTED TO DRILL INTO RECANNULATED HOLE DEEPER INTO S1 SO HE COULD ALLOW THE SCREW TO ADVANCE. WITH NO DRILL OPTION, THE AIMING DEVICE WAS ELECTED TO BE TAKEN OFF AND THE AWL "FREEHAND" WAS USED WHICH IS NOT SUGGESTED IN THE TECHNIQUE GUIDE. THE SCREW WAS PLACED WITHOUT THE AIMING DEVICE ATTACHED TO THE SPACER. U

  Patient problems: No Code Available

  MAUDE report 8044105 ↗
• MalfunctionDec 20, 2016Device Operates Differently Than Expected; Difficult to Advance; Device Operates Differently Than Expected; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN SPINE PROCEDURE, WHILE USING AN ANGLED AWL TO PENETRATE THE VERTEBRAL BODY, THE SURGEON HAD DIFFICULTY WHILE PREPARING THREE (3) SITES FOR IMPLANTATION. THE SURGEON BELIEVES THAT THE SHOULDER OF THE AWL WAS BECOMING HUNG UP ON THE AIMING DEVICE, CAUSING THE AWL TO FAIL TO ADVANCE THROUGH THE VERTEBRAE. AFTER MULTIPLE ATTEMPTS AT EACH SITE, THE SURGEON UTILIZED A MALLET TO SUCCESSFULLY PENETRATE THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. NO ADVERSE EVENTS WERE REPORTED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HOSPITAL MALLET (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS IS REPORT NUMBER 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6191335 ↗
• MalfunctionDec 20, 2016Device Operates Differently Than Expected; Difficult to Advance; Device Operates Differently Than Expected; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN SPINE PROCEDURE, WHILE USING AN ANGLED AWL TO PENETRATE THE VERTEBRAL BODY, THE SURGEON HAD DIFFICULTY WHILE PREPARING THREE (3) SITES FOR IMPLANTATION. THE SURGEON BELIEVES THAT THE SHOULDER OF THE AWL WAS BECOMING HUNG UP ON THE AIMING DEVICE, CAUSING THE AWL TO FAIL TO ADVANCE THROUGH THE VERTEBRAE. AFTER MULTIPLE ATTEMPTS AT EACH SITE, THE SURGEON UTILIZED A MALLET TO SUCCESSFULLY PENETRATE THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. NO ADVERSE EVENTS WERE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN HOSPITAL MALLET (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS IS REPORT NUMBER 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6191175 ↗