NA 387.282Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034770963), received between Nov 10, 2017 and Nov 29, 2022 — classified as 6 malfunctions.

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

• MalfunctionNov 29, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DUE TO WEAR AND TEAR AND OVERUSE, THE HANDLE FOR THE SCLP SCREWDRIVER FOR EXPANDING SCREW HEAD SCREWS BROKE INTRAOPERATIVELY. TWO ADDITIONAL INSTRUMENTS WERE ALSO BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877494 ↗
• MalfunctionNov 29, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DUE TO WEAR AND TEAR AND OVERUSE, THE HANDLE FOR THE SCLP SCREWDRIVER FOR EXPANDING SCREW HEAD SCREWS BROKE INTRAOPERATIVELY. TWO ADDITIONAL INSTRUMENTS WERE ALSO BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877490 ↗
• MalfunctionNov 29, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DUE TO WEAR AND TEAR AND OVERUSE, THE HANDLE FOR THE SCLP SCREWDRIVER FOR EXPANDING SCREW HEAD SCREWS BROKE INTRAOPERATIVELY. TWO ADDITIONAL INSTRUMENTS WERE ALSO BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877489 ↗
• MalfunctionFeb 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF THE SCREWDRIVER BROKE DURING AN UNKNOWN PROCEDURE. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER FOR EXPANSION HEAD SCREWS THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416850 ↗
• MalfunctionFeb 1, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PIECE OF THE HANDLE BROKE OFF DURING SCREW INSERTION. NO FRAGMENTS WAS REPORTED FALLING INTO THE PATIENT. SURGERY WAS COMPLETED WITH A SECOND DRIVER INCLUDED IN THE SET. NO CHARGE REPLACEMENT WILL BE NEEDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656214 ↗
• MalfunctionNov 10, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS A REPORTED THAT A SURGEON WAS INSERTING AN EXPANSION HEAD SCREW AND THE SCREWDRIVER HANDLE BROKE DURING AN ANTERIOR CERVICAL DISCECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE. THERE IS 1 DEVICE IN THIS COMPLAINT CONCOMITANT DEVICES REPORTED: EXPANSION HEAD SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7022651 ↗