NA 03.610.602Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034713670), received between Dec 27, 2016 and Jul 11, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED TO CONFIRM THAT A SMALL FRAGMENT OF THE LEG WAS GENERATED THAT BROKE OFF WHEN THE SCREWDRIVER WAS IN IT, BUT IT COULD BE REMOVED WITHOUT ANY COMPLICATIONS AND ANY ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725342 ↗
• MalfunctionJan 9, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON DECEMBER 12, 2023, WHILE ADJUSTING SCREWS, THE DISTAL EXTENSIONS OF THE SCREWDRIVER BECAME TWISTED. THE SURGERY IS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM. THIS REPORT IS FOR SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477695 ↗
• MalfunctionNov 15, 2022Compatibility Problem; Compatibility Problem

  THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796672 ↗
• MalfunctionOct 6, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SCREWDRIVER DID NOT ADJUST PROPERLY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583691 ↗
• MalfunctionDec 16, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A TRAUMATOLOGICAL ANTERIOR CERVICAL FIXATION THE CERVICAL SPINE LOCKING PLATE (CSLP)-VARIABLE ANGLE (VA) SYSTEM WITH QUICKLOCK SCREWS WAS USED. BECAUSE THE SCREWDRIVERS ALREADY SHOWED SIGNS OF WEAR, THEY HAD BEEN PREVIOUSLY REMOVED FROM THE SET AND A PAIR OF NEW ONES WERE PLACED ON THE SET INSTEAD. DURING THE PROCEDURE, WHEN IT CAME TO THE NEXT STEP OF INSERTING THE SCREWS, THE OR SCRUB NURSE COULD NOT INSERT THE SCREWDRIVER INTO THE SCREW (WHEN IT WAS RESTING IN THE SCREW TRAY). BOTH THE OPERATING SURGEONS TRIED TO STICK THE SCREW ONTO THE SCREWDRIVER BUT WERE UNSUCCESSFUL. THEY COULD ONLY INSERT THE SCREWDRIVER INTO THE SCREW IF THEY HELD BOTH PIECES WITH THEIR HANDS, HOWEVER THE RETENTION WAS LESS THAN A FRACTION OF A MILLIMETER. BECAUSE THIS WAS INSUFFICIENTLY STABLE TO BE INSERTED, THEY HAD TO USE A BACKUP AND COMPLETED THE PROCEDURE WITH THE NORMAL CSLP SCREWS AND INSTRUMENTS. THE SCREWDRIVER BLADES ARE TOO WIDE FOR THE SPACES IN THE SCREW AND CANNOT BE INSERTED INTO THE SCREW. ONE OF THE SCREWDRIVERS WAS MODIFIED BY THE HOSPITAL IN-HOUSE AFTER THE PROCEDURE IN ORDER TO ATTEMPT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11022958 ↗
• MalfunctionDec 16, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A TRAUMATOLOGICAL ANTERIOR CERVICAL FIXATION THE CERVICAL SPINE LOCKING PLATE (CSLP)-VARIABLE ANGLE (VA) SYSTEM WITH QUICKLOCK SCREWS WAS USED. BECAUSE THE SCREWDRIVERS ALREADY SHOWED SIGNS OF WEAR, THEY HAD BEEN PREVIOUSLY REMOVED FROM THE SET AND A PAIR OF NEW ONES WERE PLACED ON THE SET INSTEAD. DURING THE PROCEDURE, WHEN IT CAME TO THE NEXT STEP OF INSERTING THE SCREWS, THE OR SCRUB NURSE COULD NOT INSERT THE SCREWDRIVER INTO THE SCREW (WHEN IT WAS RESTING IN THE SCREW TRAY). BOTH THE OPERATING SURGEONS TRIED TO STICK THE SCREW ONTO THE SCREWDRIVER BUT WERE UNSUCCESSFUL. THEY COULD ONLY INSERT THE SCREWDRIVER INTO THE SCREW IF THEY HELD BOTH PIECES WITH THEIR HANDS, HOWEVER THE RETENTION WAS LESS THAN A FRACTION OF A MILLIMETER. BECAUSE THIS WAS INSUFFICIENTLY STABLE TO BE INSERTED, THEY HAD TO USE A BACKUP AND COMPLETED THE PROCEDURE WITH THE NORMAL CSLP SCREWS AND INSTRUMENTS. THE SCREWDRIVER BLADES ARE TOO WIDE FOR THE SPACES IN THE SCREW AND CANNOT BE INSERTED INTO THE SCREW. ONE OF THE SCREWDRIVERS WAS MODIFIED BY THE HOSPITAL IN-HOUSE AFTER THE PROCEDURE IN ORDER TO ATTEMPT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11022944 ↗
• MalfunctionSep 25, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DISTAL TIP OF A SCREWDRIVER WAS WORN AND WON¿T ATTACH TO SCREW PROPERLY. IT WAS UNKNOWN WHEN AND HOW IT¿S OCCURRED. PROCEDURE AND PATIENT INFORMATION WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10590086 ↗
• MalfunctionOct 31, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SCREWDRIVER FOR QUICK LOCK SCREWS DID NOT WORK PROPERLY INTRAOPERATIVELY ON (B)(6) 2019. THE INSTRUMENT DID NOT HOLD THE SCREWS AND THE SCREWS FELL OFF WHEN THEY WERE MOUNTED TO BE IMPLANTED. THE SAME SCREWDRIVER BROKE WHEN TRYING TO SCREW THE IMPLANTS. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); UNKNOWN IMPLANT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260984 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2018, THE TIP OF THE SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7677476 ↗
• MalfunctionJun 19, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, DURING THE PROCEDURE, THE CUSTOMER OPENED THE SET AND CHECKED THE INSTRUMENTS, WENT TO LOAD A SCREW AND ONE OF THE SPOKES THAT ATTACHES TO THE SCREW SNAPPED OFF. THERE WAS NO IMPACT TO THE PATIENT. THEY HAD TO OPEN AND USE A DIFFERENT KIT. CONCOMITANT DEVICE REPORTED: SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614002 ↗
• MalfunctionOct 6, 2017Break; Break

  IT WAS REPORTED THAT WHILE THE SALES CONSULTANT WAS CHECKING THE SET HE DISCOVERED THAT THE PRONGS AT THE TIP OF TWO SCREWDRIVERS WERE BROKEN OFF. HE ALSO DISCOVERED THAT ALL THE PRONGS AT THE END OF ONE OF THE LOCKING SCREWDRIVERS WERE DEFORMED AND WOULD NOT FIT IN A SCREW, AND THAT ONE OF THE PRONGS AT THE END OF A DRILL GUIDE HAD SNAPPED OFF AND WAS MISSING. THERE WAS NO PATIENT AND SURGICAL PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS WITH BROKEN PRONG TIP. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6925786 ↗
• MalfunctionOct 5, 2017Break; Break

  THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6919002 ↗
• MalfunctionJun 14, 2017Bent; Break; Bent; Break

  IT WAS REPORTED THAT DURING THE INSPECTION OF FIELD EQUIPMENT ON (B)(6) 2017, A SELF-RETAINING SCREW DRIVERS FOR QUICK LOCK SCREWS WAS NOTED TO HAVE PRONGS ON THE TIP OF THE DEVICE THAT WERE BENT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICE WAS BEING EVALUATED BY THE MANUFACTURER, IT WAS ALSO NOTED THAT ONE OF THE PRONGS WAS BROKEN. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6641231 ↗
• MalfunctionFeb 6, 2017Break; Component Missing; Break; Component Missing

  UPDATED INFORMATION ON REPORTED EVENT: IT WAS REPORTED THAT TWO (2) SELF-RETAINING SCREWDRIVERS FOR QUICK LOCK SCREWS BROKE DURING INSPECTION OF EQUIPMENT. IT WAS NOTED THE PRONGS AT THE END OF THE SCREW DRIVERS WERE BROKEN OFF AND THAT IN ADDITION TO THE BROKEN PRONGS, THE REMAINING PRONGS WERE FOUND TO BE BENT SLIGHTLY OUTWARD AND IN THE DIRECTION OF THE SCREW INSERTION. THE BALANCE OF THE DEVICE IS IN GOOD CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6303261 ↗
• MalfunctionFeb 6, 2017Break; Component Missing; Break; Component Missing

  UPDATED INFORMATION ON REPORTED EVENT: IT WAS REPORTED THAT TWO (2) SELF-RETAINING SCREWDRIVERS FOR QUICK LOCK SCREWS BROKE DURING INSPECTION OF EQUIPMENT. IT WAS NOTED THE PRONGS AT THE END OF THE SCREW DRIVERS WERE BROKEN OFF AND THAT IN ADDITION TO THE BROKEN PRONGS, THE REMAINING PRONGS WERE FOUND TO BE BENT SLIGHTLY OUTWARD AND IN THE DIRECTION OF THE SCREW INSERTION. THE BALANCE OF THE DEVICE IS IN GOOD CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6303255 ↗
• MalfunctionDec 30, 2016Break; Break

  IT WAS REPORTED THAT THE TIPS WERE BROKEN ON THE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX AND SELF-RETAINING SCREWDRIVER FOR QUICK LOCKS SCREWS. THIS WAS NOTICED DURING INSPECTION AND NOT IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6216352 ↗
• MalfunctionDec 27, 2016Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO OF THE SELF-RETAINING SCREWDRIVERS FOR QUICK LOCK SCREWS ARE DEFORMED. THE TIP OF ONE LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS ALSO DEFORMED. ANOTHER LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS MISSING TWO PIECES. ALL FOUR DEVICES WERE FOUND IN THE STERILE PROCESSING ROOM DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICES WERE RECEIVED BY THE MANUFACTURER IT WAS NOTED THAT ALL THE DEVICES WERE FOUND TO HAVE BROKEN TIPS. THIS IS REPORT 2 OF 4 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6206202 ↗
• MalfunctionDec 27, 2016Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO OF THE SELF-RETAINING SCREWDRIVERS FOR QUICK LOCK SCREWS ARE DEFORMED. THE TIP OF ONE LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS ALSO DEFORMED. ANOTHER LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS MISSING TWO PIECES. ALL FOUR DEVICES WERE FOUND IN THE STERILE PROCESSING ROOM DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICES WERE RECEIVED BY THE MANUFACTURER IT WAS NOTED THAT ALL THE DEVICES WERE FOUND TO HAVE BROKEN TIPS. THIS IS REPORT 1 OF 4 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6206182 ↗