NA 389.829Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034776835), received between Aug 8, 2019 and Nov 29, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 2, 2023, THE SCREWDRIVER STRIPPED WHILE USING THE FINAL TIGHTENER DURING A LATERAL CORPECTOMY PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ALTERNATIVE INSTRUMENTS IN THE SET WERE UTILIZED. THIS REPORT INVOLVES ONE 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18226835 ↗
• MalfunctionJun 3, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED DAMAGED AT THE LOCAL DC. THE DEVICE WAS UNABLE TO ATTACH TO THE SCREWDRIVER SHAFT, AND COULDN¿T HOLD THE SCREW. THIS REPORT IS FOR A 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935794 ↗
• MalfunctionAug 8, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING ANTERIOR LUMBAR INTERBODY FUSION (ALIF) L4-L5 PROCEDURE ON (B)(6) 2019, THE HEXAGONAL SCREWDRIVER FROM THE ANTERIOR TENSION BAND (ATB) PLATE SYSTEM WAS NOT LOCKING OFF AND HAS NO CLEAR CLICK SOUND WHEN LOCKING THE SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ATB SET. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.  UPON MANUFACTURER'S INVESTIGATION OF THE RECEIVED COMPLAINT DEVICE IT CAN BE SEEN THAT THE HEXAGONAL TIP IS SLIGHTLY TWISTED AS WELL SOME EDGES ARE DEFORMED CONCOMITANT DEVICE/S REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), SCREWDRIVER (PART # 287110550, LOT # UNKNOWN, QUANTITY 1)  THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875562 ↗