NA 313.99Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982188328), received between Aug 22, 2019 and Aug 28, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREW DRIVER BROKE. THERE WAS PATIENT INVOLVEMENT. NO OTHER INFORMATION REPORTED. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20089057 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HANDLES ARE FALLING APART. THE EVENT OCCURRED DURING STERILE PROCESSING, CALIBRATION AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER HOLDING SLEEVE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054364 ↗
• MalfunctionJan 6, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER IS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118201 ↗
• MalfunctionApr 15, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CRUCIFORM SCREWDRIVER HANDLE WAS STARTING TO FLAKE. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120687 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE CRUCIFORM SCREWDRIVER HOLDING SLEEVE BROKE. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CRUCIFORM SCREWDRIVER HOLDING SLEEVE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367566 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A HARDWARE REMOVAL OPERATION. THE TWO (2) DRIVERS, SCREWDRIVER SHAFT AND SCREWDRIVER WITH HOLDING SLEEVE HAD BROKEN DURING SCREW REMOVAL CASES, AND THAT A SCREWDRIVER HANDLE WAS NOT QUICK CONNECTING TO DRIVE SHAFTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY AND NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE. THIS REPORT IS 3 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592218 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10012216 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF FIVE (5) UNKNOWN SCREWS AND AN UNKNOWN PLATE OF THE FIFTH METACARPAL DUE TO PAIN. HOWEVER, THE TIP OF A CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE BROKE WHEN TRYING TO REMOVE AN UNKNOWN LAST SCREW. THE BROKEN PIECES OF THE SCREWDRIVER WERE REMOVED WITH EASE. MOREOVER, THE SURGEON HAD DIFFICULTY REMOVING THE LAST SCREW BECAUSE THE PLATE AND THE SCREW WERE WELDED TOGETHER, AND THE SCREW WOULD NOT BUDGE. CONSEQUENTLY, THE PART OF THE PLATE AND A SCREW WERE LEFT IN THE PATIENT'S BODY. RESULTING, THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 20 MINUTES DUE TO AN ADDITIONAL TRAY NEEDED AND CUTTING OF THE PLATE. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART #, LOT # UNKNOWN, QUANTITY# 4). THIS IS REPORT 1 FOR 3 (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient; Pain

  MAUDE report 9117067 ↗
• MalfunctionAug 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER STERILIZATION, IT WAS NOTICED THAT THE FOLLOWING WOOD HANDLE SCREWDRIVERS HAD A LEAKING DYE; ONE (1) CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE, TEN (10) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE, ONE (1) LARGE SCREWDRIVER, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER, AND FIVE (5) STAR DRIVE SCREWDRIVER. ALL THESE WOOD HANDLE SCREWDRIVERS ARE LEAKING DYE INTO THE TRAYS AS THEY HAVE BEEN THROUGH COUNTLESS STERILIZATIONS AND BEEN IN CIRCULATION FOR MANY YEARS. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT CAPTURES (8) EIGHT OUT OF 18 DEVICES, REMAINING DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8920702 ↗