NA 311.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10887587035673), received between Dec 20, 2016 and Aug 31, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519087 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  DURING THE SURGERY, WHILE THE DOCTOR WAS USING THE SCREWDRIVER, A DIFFICULTY AROSE IN DISENGAGING THE HANDLE FROM THE BLADE. AN ATTEMPT WAS MADE TO REATTACH THE HANDLE TO THE BLADE, BUT A PROPER CONNECTION COULD NOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057347 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT THE ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE. THERE WERE METAL SHAVINGS THAT APPEARED TO BE COMING OUT OF HANDLE. THIS IS NOT DURING SURGERY. NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662914 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT THE ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE. THERE WERE METAL SHAVINGS THAT APPEARED TO BE COMING OUT OF HANDLE. THIS IS NOT DURING SURGERY. NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644415 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED THAT THE RATCHETING HANDLE WAS BROKEN. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. A DIFFERENT SCREWDRIVER HANDLE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284441 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE HANDLE WAS GETTING STUCK. TO ACTIVATE THE RACHE SYSTEM, SPECIALIST EXPRESSED DISAGREEMENT. DRILL BITS WERE WITHOUT EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106556 ↗
• MalfunctionJan 14, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147748 ↗
• MalfunctionDec 30, 2024Material Integrity Problem; Material Integrity Problem

  THE PRODUCT DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035351 ↗
• MalfunctionDec 30, 2024Material Integrity Problem; Material Integrity Problem

  THE PRODUCT DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035178 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 25, 2024, UPON ROUTINE INSPECTION BY THE SALES CONSULTANT, IT WAS DISCOVERED THAT THE RATCHETING SCREWDRIVER HANDLE WAS MALFUNCTIONING. THE SCREWDRIVER HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867657 ↗
• MalfunctionNov 14, 2024Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE TESTING OF FIELD EQUIPMENT THE SCREWDRIVER WAS NOT WORKING PROPERLY. IT WAS FOUND THAT THE SCREWDRIVER SLIPS WHILE TRYING TO SCREW. IT DID NOT CAUSED ANY PROBLEM OR DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684084 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024 THE REPORTED PRODUCT NOT HOLDING SCREWDRIVER BLADES OR SWITCHING FROM RATCHET TO REVERSE. THE ISSUE WAS OBSERVED DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266300 ↗
• MalfunctionSep 20, 2024Electrical /Electronic Property Problem; Device-Device Incompatibility; Electrical /Electronic Property Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RATCHETING SCREWDRIVER HANDLE NOT HOLDING SCREWDRIVER BLADES OR SWITCHING FROM RATCHET TO REVERSE. THE ISSUE WAS OBSERVED DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266127 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON SEPTEMBER 10, 2024, THE RATCHETING SCREWDRIVER HANDLE WAS NOT HOLDING SCREWDRIVER BLADES OR SWITCHING FROM RATCHET TO REVERSE. THE ISSUE WAS OBSERVED DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266018 ↗
• MalfunctionSep 16, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE ITEM WAS NOT LOCKING THE SCREWDRIVER BLADE IN PLACE. ADDITIONALLY, THE MECHANISM THAT HOLDS THE BLADE SEEMED TO BE DISCONNECTED FROM HANDLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20224060 ↗
• MalfunctionAug 21, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RATCHET HANDLE IS NO LONGER OPERATIONAL. "THE SLIDING LATCH BROKE AND IT WILL NOT LOCK ANY DRIVER INTO PLACE. THERE WERE NO PATIENT INVOLVEMENT, THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018794 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICES ARE BROKEN/FAULTY FROM OVERUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4). THIS (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721153 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICES ARE BROKEN/FAULTY FROM OVERUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4). THIS (B)(4) IS RELATED TO (B)(4). WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721119 ↗
• MalfunctionFeb 22, 2024Electrical /Electronic Property Problem; Mechanical Jam; Electrical /Electronic Property Problem; Mechanical Jam

  IT WAS REPORTED THAT THE RATCHETING SCREWDRIVER HANDLE SLIDER HANDLE IS STUCK. IT IS UNABLE TO BE PUSHED TO FORWARD OR REVERSE SETTING. THE ISSUE WAS OBSERVED DURING PRE-OP THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18761109 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE SEVERAL SCREWDRIVERS WERE BROKEN. RATCHETING SCREWDRIVERS WERE BROKEN. ONE HANDLE HAS A BLADE STUCK IN IT, THAT WILL NOT COME OUT AND THE OTHER HANDLE WILL NOT TURN AT ALL WITH THE BOTTOM COMING OUT. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR (1) RATCHETING SCREWDRIVER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051256 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE SEVERAL SCREWDRIVERS WERE BROKEN. RATCHETING SCREWDRIVERS WERE BROKEN. ONE HANDLE HAS A BLADE STUCK IN IT, THAT WILL NOT COME OUT AND THE OTHER HANDLE WILL NOT TURN AT ALL WITH THE BOTTOM COMING OUT. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR (1) RATCHETING SCREWDRIVER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051106 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE REST OF THE TRAY, IT WAS NOTICED THAT THE BLACK RATCHETING SCREWDRIVER HANDLE WAS BROKEN. THERE IS A CRACK IN THE HANDLE, CAUSING THE SCREWDRIVER HANDLE TO NOT FUNCTION CORRECTLY. IT WILL NO LONGER RATCHET FORWARD. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938630 ↗
• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MARCH 30, 2023, THE RATCHETING SCREWDRIVER HANDLE WOULD NOT RATCHET. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT; THIS WAS DISCOVERED DURING INSPECTION PRE-OPERATIVELY. THIS REPORT INVOLVES ONE RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763661 ↗
• MalfunctionFeb 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING CASE. IT WAS ISSUES WITH BOTH RATCHETING HANDLE AND DEPTH GAUGE. THE DEPTH GAUGE WAS VERY STICKY. THERE WAS NO SURGICAL DELAY AND NO REPORTED PATIENT CONSEQUENCES. THIS COMPLAIN INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295832 ↗
• MalfunctionJan 10, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TOP WAS STUCK, AND IT WILL NOT RATCHET FORWARD. THERE WERE NO PATIENT CONSEQUENCES, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131289 ↗