NA 387.284Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034770970), received between May 26, 2017 and Nov 10, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE SCREWDRIVERS BROKE FROM NORMAL USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509644 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION, THE SELF RETAINING SCREWDRIVER FOR LOCKING SCREW WAS BROKEN BUT DID NOT HAVE ANY PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10319625 ↗
• MalfunctionJan 28, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE FOR AN UNKNOWN REASON. DURING THE PROCEDURE, THE CERVICAL SPINE LOCKING SCREWDRIVER HANDLE WAS BROKEN INTO SEVERAL PIECES. IT IS UNKNOWN HOW THE DEVICE BROKE. IT IS UNKNOWN IF THE FRAGMENTS GENERATED FROM THE BROKEN DEVICE WERE REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281534 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED THAT DURING A FIELD INVENTORY INSPECTION ON JULY 2, 2018, A SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW WAS FOUND TO HAVE A BROKEN TIP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7728869 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THE HANDLE WAS BROKEN ON A CERVICAL SPINE LOCKING PLATE (CSLP) SELF-RETAINING SCREWDRIVER. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7678529 ↗
• MalfunctionJul 9, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE HANDLE OF A SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW WAS DISCOVERED BROKEN BY THE CENTRAL STERILE DEPARTMENT. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7670962 ↗
• MalfunctionMay 26, 2017Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLE FOR THE CERVICAL SPINE LOCKING PLATE (CSLP) BROKE ON AN UNKNOWN DATE. THE HANDLE WAS DISCOVERED BROKEN WHEN THE TRAYS WERE BEING PUT BACK TOGETHER ON (B)(6) 2017. THE HANDLE HAD BEEN USED IN A SURGERY ON (B)(6) 2017 AND IT WAS REPORTED THAT IT FUNCTIONED PROPERLY AT THE TIME OF IMPLANTATION. THERE WERE NO ISSUES REPORTED DURING OR AFTER THE SURGERY. A PORTION OF THE HANDLE WAS MISSING AND IT WAS BELIEVED THAT IT BROKE DURING OR AFTER THE DECONTAMINATION PROCESS. THE BROKEN PORTION HAS NOT BEEN LOCATED. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6595618 ↗