NA 314.482Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587037462), received between Jan 31, 2020 and Mar 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ORTHOPEDIC PROCEDURE THAT THE SCRDRIVERSHAFT 1 CRUCIF L75 W/HOLD-SLEEV DID NOT FUNCTION AS INTENDED. THE SLEEVES ON THE DEVICE FAILED TO SLIDE PROPERLY AND DID NOT HOLD SCREWS, CAUSING A DELAY IN SURGERY BY TWO MINUTES. A REPLACEMENT SCREWDRIVER WAS UTILIZED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED, AND NO PATIENT INVOLVEMENT OR CONSEQUENCES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560197 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ORTHOPEDIC PROCEDURE THAT THE SCRDRIVERSHAFT 1 CRUCIF L75 W/HOLD-SLEEV DID NOT FUNCTION AS INTENDED. THE SLEEVES ON THE DEVICE FAILED TO SLIDE PROPERLY AND DID NOT HOLD SCREWS, CAUSING A DELAY IN SURGERY BY TWO MINUTES. A REPLACEMENT SCREWDRIVER WAS UTILIZED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED, AND NO PATIENT INVOLVEMENT OR CONSEQUENCES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560196 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ORTHOPEDIC PROCEDURE THAT THE SCRDRIVER SHAFT 1 CRUCIF L75 W/HOLD-SLEEVE DID NOT FUNCTION AS INTENDED. THE SLEEVES ON THE DEVICE FAILED TO SLIDE PROPERLY AND DID NOT HOLD SCREWS, CAUSING A DELAY IN SURGERY BY TWO MINUTES. A REPLACEMENT SCREWDRIVER WAS UTILIZED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED, AND NO PATIENT INVOLVEMENT OR CONSEQUENCES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560184 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874798 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6)2023, THE DRIVER IN QUESTION SNAPPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.0MM CRUCIFORM SCRWDRVR BLADE W/SPRING HOLDING SLV-HXC. THIS IS REPORT 2 OF 2 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370706 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DRIVER IN QUESTION SNAPPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.0MM CRUCIFORM SCREWDRIVER BLADE W/SPRING HOLDING SLV-HXC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370705 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE 1.0 MM CRUCIFORM SCREWDRIVER BLADE WITH SPRING HOLDING SLEEVE HEX COUPLING WAS BROKEN. IT WAS UNKNOWN IF THERE WAS A PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1)1.0MM CRUCIFORM SCRWDRVR BLADE W/SPRING HOLDING SLV-HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775266 ↗
• MalfunctionJan 31, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE CRUCIFORM SCREWDRIVER BLADE WITH SPRING HOLDING SLEEVE, HEX COUPLING WAS NOTICED BROKEN. THE ISSUE WAS DISCOVERED DURING INSPECTION OF THE VARIABLE ANGLE HAND SET TRAY. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9654262 ↗