NA 324.052Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982191069), received between Jan 23, 2017 and Sep 4, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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.

• MalfunctionSep 4, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIP PART WAS DAMAGED AND UNABLE TO CONNECT TO SCREW HEAD. AN UNREPAIRABLE LETTER WAS ISSUED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TORQUE LIMITING SCREWDRIVER/SELF-RETAINING FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20142270 ↗
• MalfunctionMay 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER DOES NOT WORK ANYMORE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM TORQUE LIMITING SCREWDRIVER/SELF-RETAINING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19222362 ↗
• MalfunctionMar 4, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVERS IN QUESTION WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TORQUE LIMITING SCREWDRIVER/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827831 ↗
• MalfunctionDec 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A TOMOFIX OF A DISTAL FEMUR SURGERY THE TORQUE SCREWDRIVER STRIPPED. THE SCREWDRIVER WAS USED BUT IT DID NOT GRIP WELL. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 3.5MM TORQUE LIMITING SCREWDRIVER/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094961 ↗
• MalfunctionFeb 17, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2107 DUE TO A DISPLACED FRACTURE THAT OCCURRED WHEN THE PATIENT FELL POST-OPERATIVELY. WHILE USING THE 3.5 MM TORQUE LIMITED HAND DRIVER THE SURGEON WAS UNABLE TO GET THE HEAD OF THE DRIVER TO SEAT SECURELY IN THE RECESS OF THE LOCKING SCREWS. THIS IN TURN CAUSED SCREWS TO FEEL AS THOUGH THE RECESS WAS STRIPPED. UPON INSPECTION OF THE TIP OF THE HAND DRIVER, IT DID APPEAR AS THOUGH IT WAS NOT UNIFORM, AND LOOKED AS THOUGH A REPLACEMENT WAS IN ORDER. ANOTHER HAND DRIVER WAS AVAILABLE FOR USE WHICH HAD NO ADDITIONAL SURGICAL TIME ADDED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. PATIENT STATUS OUTCOME WAS REPORTED AS POSITIVE. PLEASE SEE RELATED COMPLAINT (B)(4) WHICH ADDRESSES AND REPORTS THE NEED FOR REVISION SURGERY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6341189 ↗
• MalfunctionJan 23, 2017Bent; Dull, Blunt; Material Deformation; Bent; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT DURING A HARDWARE REMOVAL SURGERY ON (B)(6) 2016, THE 3.5MM TORQUE SCREWDRIVER INSTRUMENT AND THE LARGE HEXAGONAL SCREWDRIVER INSTRUMENTS BECAME TWISTED AND BENT. THE PROCEDURE WAS PERFORMED BECAUSE THE PATIENT¿S DISTAL FEMORAL FRACTURE HAD HEALED AND THE PATIENT WAS UNCOMFORTABLE WITH THE PROMINENT EDGE OF THE LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE. THE PATIENT WAS INITIALLY IMPLANTED ON AN UNKNOWN DATE IN 2016 WITH ONE (1) TITANIUM (TI) DISTAL FEMUR LEFT LISS PLATE, THREE (3) 5.0MM TI LOCKING SCREW SELF DRILLING, TWO (2) 5.0MM TI LOCKING SCREW SELF-DRILLING 40MM AND ONE (1) 5.0MM TI LOCKING SCREW SELF DRILLING 75MM. DURING THE (B)(6) 2016 PROCEDURE, THE SURGEON ATTEMPTED TO REMOVE THE PLATE AND SCREWS. WHILE ATTEMPTING TO REMOVE TWO (2) OF THE ORIGINALLY IMPLANTED SCREWS, THE 3.5MM TORQUE SCREWDRIVER INSTRUMENT AND THE LARGE HEXAGONAL SCREWDRIVER INSTRUMENTS BECAME TWISTED, BENT WITH ROUNDED OFF EDGES. DURING THIS PROCEDURE, TWO (2) UNKNOWN 5.0MM TI LOCKING SCREWS REPORTEDLY HAD STRIPPED HEADS AND ONLY ONE (1) UNKNOWN 5.0MM TI LOCKING SCREW WAS REMOVED. THE LISS PLATE AND REMAINING SCREWS WERE LEFT IN THE PATIENT. A SECOND HARDWARE REMOVAL SURGERY WA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269211 ↗