NA 314.465Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982188908), received between Sep 25, 2019 and Jan 20, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER HANDLES ARE LEAVING STAINS ON PEEL PACKS DURING STERILIZATION, THE TIP OF DEPTH GAUGE BROKE DURING CLEANING AND SCREWDRIVER SHAFT IS WORN OUT. EVENT WAS NOTED DURING STERILE PROCESSING AND FIELD INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121347 ↗
• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVERS WERE STRIPPED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16922995 ↗
• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW DRIVERS WERE STRIPPED. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1)CRUCIFORM SCREWDRIVER SHAFT; THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807298 ↗
• InjuryMar 15, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 2.4 CRUCIFORM SCREWDRIVER WAS USED TO REMOVE A LARGE FRAGMENT PLATE WITH CRUCIFORM SCREWS FROM THE PATIENT. THE TIP OF THE SCREWDRIVER WAS BROKEN. THE PLATE AND SCREWS WERE NOT SUCCESSFULLY REMOVED. THE PATIENT WAS SCHEDULED FOR RE-OPERATION ON (B)(6) 2022. FRAGMENTS WERE GENERATED. THE PROCEDURE WAS NOT COMPLETED. THIS REPORT INVOLVES ONE (1) SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13772988 ↗
• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING STERILIZATION A SCREWDRIVER SHAFT WAS STUCK ON THE T-HANDLE SCREWDRIVER. UPON CHECKING, THE SCREWDRIVER SHAFT WAS COMPLETELY FROZEN ON THE HANDLE. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) CRUCIFORM SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288072 ↗
• MalfunctionSep 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE SCREWDRIVER WAS SNAPPED OFF. THIS WAS REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9119294 ↗