NA 03.617.904Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034717180), received between Jan 4, 2017 and Apr 6, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (21 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANGLED SCREWDRIVER AND STRAIGHT DRIVER STRIPPED DURING THE CASE. NO DELAY DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790932 ↗
• MalfunctionApr 6, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ANGLED SCREW DRIVER AND STRAIGHT DRIVER STRIPPED DURING THE CASE. NO DELAY DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790922 ↗
• MalfunctionApr 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A HARD CASE. USER'S HOUSE SET WAS 10+ YEARS OLD SO THEY HAD MULTIPLE ISSUE. THE AWL WAS BENT AND DULL SO IT WOULD NOT MAKE A WHOLE FOR THE SCREW. THE PATIENTS BONE WAS STRONG AND IT MADE THE WEAK AWL BEND. THEY THEN TRIED PUTTING THE SCREW IN AND THE ANGLED DRIVER AND STRAIGHT DRIVER STRIPPED. THE MALLET ALSO WAS NO LONGER FULLY CEMENTED ON THE SHAFT SO THEY COULDN'T BANG IN THE SCREW ONCE THE MALLET BROKE. FRAGMENTS WERE NOT GENERATED. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762664 ↗
• MalfunctionOct 18, 2024Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO FRAGMENTS GENERATED AND THERE WAS NO ALLEGATION AGAINST THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481365 ↗
• MalfunctionOct 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024 THE SCREWDRIVERS ARE STRIPPED. THE SCREWDRIVER WAS NOT RETAINING THE SCREWS. NO ADVERSE EVENT TO THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481206 ↗
• MalfunctionJul 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER TIP BROKE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740419 ↗
• MalfunctionMay 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ZERO P VA SCREW DRIVER SHAFT REQUIRES REPLACEMENT DUE TO DULLING AT THE TIPS. NO PATIENT IMPACTED/NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243717 ↗
• MalfunctionMay 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ZERO P VA SCREW DRIVER SHAFT REQUIRES REPLACEMENT DUE TO DULLING AT THE TIPS. NO PATIENT IMPACTED/NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243714 ↗
• MalfunctionMar 14, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ZERO-P LORDOTIC IMPLANT AND SCREWS IN QUESTION THAT WERE ORIGINALLY IMPLANTED IN C2-3 ACDF HAD TO BE REMOVED DUE TO THE SCREWDRIVER SHAFT AND SCREW HEADS STRIPPING DURING INSERTING. THEY WERE REPLACED WITH A MTF FREEZE DRIED ALLOGRAFT SPACER AND PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND THE EXTENDED USE OF FLUOROSCOPY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904006 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVER TIP WAS BROKEN AND WAS RETRIEVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887189 ↗
• MalfunctionDec 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THE DISTAL TIP OF TWO (2) T8 SELF-HOLDING DRIVERS ARE WORN. IT WAS IDENTIFIED PRIOR TO STARTING THE PROCEDURE SO THERE WAS NO PATIENT IMPACT. BACK UP SET WAS USED INSTEAD. THIS REPORT IS FOR A SELF-HOLDING SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371679 ↗
• MalfunctionDec 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THE DISTAL TIP OF TWO (2) T8 SELF-HOLDING DRIVERS ARE WORN. IT WAS IDENTIFIED PRIOR TO STARTING THE PROCEDURE SO THERE WAS NO PATIENT IMPACT. BACK UP SET WAS USED INSTEAD. THIS REPORT IS FOR A SELF-HOLDING SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371659 ↗
• MalfunctionNov 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2023, THE TIP OF THE DRIVER WAS BROKEN. THE FRAGMENT WAS EASILY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055687 ↗
• MalfunctionJul 14, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE T8 STARDRIVE SCREWDRIVER SHAFT WAS FOUND TO BE STRIPPED. IT WAS NOT POSSIBLE TO LOAD A SCREW, SO THE SURGEON USED ANOTHER SCREWDRIVER FROM THE SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327121 ↗
• MalfunctionJun 15, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) A SCREW DRIVER WAS STRIPPED AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT. THIS WAS NOTED DURING TRAY ASSEMBLY. THIS REPORT INVOLVES ONE SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133659 ↗
• MalfunctionMar 8, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW INSERTERS HAS BECOME WORN AT THE DISTAL TIP AND WAS NO LONGER SELF RETAINING SCREWS RELIABLY WHICH NEEDS REPLACEMENT. NO PATIENT INVOLVEMENT AND NO CASE IMPACTED. ALL OF THE FOUR(4) DEFECTIVE SHAFTS WILL BE RETURNED ONCE NEW ONES ARRIVE. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503510 ↗
• MalfunctionMar 8, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW INSERTERS HAS BECOME WORN AT THE DISTAL TIP AND WAS NO LONGER SELF RETAINING SCREWS RELIABLY WHICH NEEDS REPLACEMENT. NO PATIENT INVOLVEMENT AND NO CASE IMPACTED. ALL OF THE FOUR(4) DEFECTIVE SHAFTS WILL BE RETURNED ONCE NEW ONES ARRIVE THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503507 ↗
• MalfunctionMar 8, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW INSERTERS HAS BECOME WORN AT THE DISTAL TIP AND WAS NO LONGER SELF RETAINING SCREWS RELIABLY WHICH NEEDS REPLACEMENT. NO PATIENT INVOLVEMENT AND NO CASE IMPACTED. ALL OF THE FOUR(4) DEFECTIVE SHAFTS WILL BE RETURNED ONCE NEW ONES ARRIVE. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503492 ↗
• MalfunctionMar 8, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW INSERTERS HAS BECOME WORN AT THE DISTAL TIP AND WAS NO LONGER SELF RETAINING SCREWS RELIABLY WHICH NEEDS REPLACEMENT. NO PATIENT INVOLVEMENT AND NO CASE IMPACTED. ALL OF THE FOUR(4) DEFECTIVE SHAFTS WILL BE RETURNED ONCE NEW ONES ARRIVE THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503486 ↗
• MalfunctionJan 26, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL PROCEDURE ON (B)(6) 2023, THE SURGEON WAS INSERTING A SELF-TAPPING SCREW INTO A ZERO P VA IMPLANT WHEN IT WAS NOTED THAT THE SCREW WAS NOT BEING ENGAGED PROPERLY BY THE DRIVER. THE SURGEON CHANGED TO ANOTHER SCREWDRIVER SHAFT WITHIN THE INSTRUMENT SET, AND HE PROCEEDED WITH THE CASE. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245761 ↗
• MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE TIPS OF TWO (2) SCREW INSERTERS WERE BOTH USED/STRIPPED AND NEEDED REPLACING. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10805324 ↗
• MalfunctionNov 6, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE TIPS OF TWO (2) SCREW INSERTERS WERE BOTH USED/STRIPPED AND NEEDED REPLACING. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10805303 ↗
• MalfunctionMar 13, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING AN INSPECTION OF FIELD EQUIPMENT ON (B)(6) 2018, IT WAS NOTED THAT TWO (2) SCREW INSERTERS WERE STRIPPED. ALTHOUGH DEVICES USED IN THE PAST BY VARIOUS HOSPITAL ACCOUNTS THE DEVICE MALFUNCTIONS WERE NOTED OUTSIDE OF ANY HOSPITAL AND IT WAS CONFIRMED THAT NO PATIENT OR SURGICAL PROCEDURE WAS IMPACTED. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7335834 ↗
• MalfunctionMar 13, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING AN INSPECTION OF FIELD EQUIPMENT ON (B)(6) 2018, IT WAS NOTED THAT TWO (2) SCREW INSERTERS WERE STRIPPED. ALTHOUGH DEVICES USED IN THE PAST BY VARIOUS HOSPITAL ACCOUNTS THE DEVICE MALFUNCTIONS WERE NOTED OUTSIDE OF ANY HOSPITAL AND IT WAS CONFIRMED THAT NO PATIENT OR SURGICAL PROCEDURE WAS IMPACTED. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7335788 ↗
• InjuryNov 30, 2017Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT INITIAL ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE. DURING THE SURGERY, WHILE PLACING ZERO P VA SCREWS, SURGEON HAD SOME DIFFICULTY WITH THE DRIVERS. THE TWO DRIVERS WERE WORN OUT AND THE TWO HANDLES WERE SQUEAKING. AS NO ADDITIONAL SCREWDRIVERS WERE READILY AVAILABLE OR USE, THE SURGEON CHANGED TO DEPUY SPINE SKYLINE PLATE AND SCREWS AND USED A SYNTHES ACIS INTERBODY SPACER. THERE WAS 5 MINUTES DELAY IN PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE POST OPERATIVELY. THERE WAS NO PATIENT HARM REPORTED. CONCOMITANT DEVICE REPORTED: ZERO P VA SCREWS (PART # UNKNOWN. LOT # UNKNOWN, QUANTITY - UNKNOWN). THIS REPORT IS FOR ONE (1) SCREW INSERTER T8 SELF-RETAINING/QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7072622 ↗