NA 1806-0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540520418), received between May 2, 2018 and Jun 19, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Fracture

  AS REPORTED: "TIP OF SCREWDRIVER BROKE OFF"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564135 ↗
• MalfunctionMar 10, 2026Fracture

  AS REPORTED: "SCREWDRIVER EXTRA SHORT 3.5MM  1806-0203/1 BROKE DURING EXTRACTION OF T2 PHN 5MM SCREW. THE SCREW GAVE RESISTANCE DURING REMOVAL. WHEN THE SCREW WAS PARTIALLY REMOVED THE SCREWDRIVER BROKE".

  Patient problems: Foreign Body In Patient

  MAUDE report 24560110 ↗
• MalfunctionOct 16, 2025Fracture; Fracture

  AS REPORTED: "CUSTOMER CONTACTED ME REGARDING A SCREWDRIVER THEY SAID WAS BROKEN."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317235 ↗
• MalfunctionAug 19, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING INSPECTION IT WAS FOUND THAT THE SCREWDRIVER HEAD WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840669 ↗
• MalfunctionJan 15, 2025Break; Fracture; Break; Fracture

  CUSTOMER REPORTED A BROKEN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164496 ↗
• MalfunctionJan 13, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "SCREWDRIVER TIP IS BROKEN AND PREVENTS SLEEVE SUPPORT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143540 ↗
• MalfunctionDec 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "SCREWDRIVER TIP IS BROKEN OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918808 ↗
• MalfunctionOct 15, 2024Break; Fracture; Break; Fracture

  CUSTOMER REPORT THROUGH SALES REP THAT DEVICE HAS SNAPPED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457736 ↗
• MalfunctionJul 30, 2024Break; Fracture; Break; Fracture

  IN A NAIL REMOVAL CASE, THREE SCREWS WERE REMOVED, AND WHEN THE FOURTH SCREW WAS ABOUT TO BE REMOVED, THE SCREWDRIVER BROKE. THE FOURTH SCREW WAS IMMEDIATELY REMOVED USING ANOTHER SCREWDRIVER, AND THE OPERATION PROCEEDED WITHOUT INTERRUPTION. BEFORE CLOSING, SURGEON CONFIRMED THAT THERE WERE NO METAL FRAGMENTS DUE TO THE BROKEN SCREWDRIVER BY C-ARM AND X-RAY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860064 ↗
• MalfunctionJul 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: BROKEN SCREWDRIVER AT THE TIP WHICH DOES NOT ALLOW THE SCREW TO GRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732321 ↗
• MalfunctionAug 14, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE SELF-HOLDING SCREWDRIVER EXTRA SHORT SEEMED TO HAVE BROKEN OFF DURING THE NAIL EXTRACTION OPERATION, AND WHEN THE INSTRUMENT WAS RETURNED AFTER THE SURGERY, THE BREAKAGE WAS CONFIRMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546141 ↗
• MalfunctionJul 18, 2023Crack; Crack

  AS REPORTED: "THE SELF-LATCHING SCREWDRIVER DID NOT HOLD THE SCREWS, A CRACK IN THE METAL NEXT TO THE BLADE WAS SPOTTED. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347347 ↗
• MalfunctionDec 21, 2021Break; Break

  AS REPORTED:"TIP OF SCREWDRIVER BROKE WHILE INSERTING 5.0 SCREW"

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057637 ↗
• MalfunctionMar 16, 2021Break; Material Deformation; Break; Material Deformation

  AS REPORTED: "AT THE TIME OF THE PROXIMAL SIDE STOP, EVEN THOUGH THE SURGEON DRILLED WITH THE TARGET DEVICE, IT FELT LIKE IT WAS JUST BARELY IN, AND THE SCREW DID NOT GO IN BEYOND THE SLEEVE. THEN THE SURGEON REMOVED THE TARGET DEVICE AND ATTACHED THE SCREW TO THE SELF-HOLDING DRIVE, DRIVER'S TIP WAS CHIPPED BECAUSE IT LOST THE TORQUE OF THE NAIL AND BONE. THEREAFTER, THE SURGEON WAS ABLE TO REATTACH IT TO THE LONG SELF-HOLDING DRIVER AGAIN AND THE OPERATION WAS COMPLETED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499122 ↗
• MalfunctionJan 18, 2021Fracture; Fracture

  THE CUSTOMER REPORTED TO FREDERIC VAUGES (SR) THAT : "WE NOTICED A CLEAR BREAKAGE OF ONE OF YOUR SCREWDRIVERS. REF : REF 1806-0203/1, LOT KMW351702 (FOR THE SCREWDRIVER PART) AND REF 1806-0203/2, LOT KMW350701 (FOR THE PART THAT FITS ON THE SCREWDRIVER)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189780 ↗
• MalfunctionJan 18, 2021Fracture; Fracture

  THE CUSTOMER REPORTED TO FREDERIC VAUGES (SR) THAT : "WE NOTICED A CLEAR BREAKAGE OF ONE OF YOUR SCREWDRIVERS. REF : REF 1806-0203/1, LOT KMW351702 (FOR THE SCREWDRIVER PART) AND REF 1806-0203/2, LOT KMW350701 (FOR THE PART THAT FITS ON THE SCREWDRIVER)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189777 ↗
• MalfunctionFeb 24, 2020Break; Break

  AS REPORTED: "AN EXTRA SHORT SCREWDRIVER WAS USED TO INSERT THE SCREW, BUT IT COULD NOT BE INSERTED SUCCESSFULLY. THE SCREW WAS REMOVED ONCE AND REINSERTED USING ANOTHER EXTRA SHORT SCREWDRIVER. THEREAFTER, THE PROCEDURE CONTINUED USING THE SECOND EXTRA SHORT SCREWDRIVER AND COMPLETED WITHOUT ANY PROBLEM. IT WAS NOTICED THE DRIVER WHICH WAS USED INITIALLY WAS BROKEN BUT CONFIRMED THAT THERE WERE NO BROKEN PIECES REMAINED INSIDE THE PATIENT BODY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9748374 ↗
• MalfunctionJan 31, 2020Break; Break

  PRIMARY PROCEDURE, LEFT GAMMA LONG NAIL. IT WAS REPORTED THAT THE THREADS OF THE DRIVER BROKE WHEN TIGHTENING THE 5MM SCREW. THE LONG DRIVER FROM THE SET WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A DELAY OF LESS THAN 1 MINUTE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9656068 ↗
• MalfunctionApr 4, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT, DURING GAMMA SURGERY, SCREW DRIVERS WERE BROKEN. DISCOVERY WAS MADE UPON INSPECTION AFTER THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY A ONE MINUTE DELAY. NO FURTHER INFORMATION PROVIDED FROM THE HOSPITAL OR THE SURGEON. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483032 ↗
• MalfunctionMar 22, 2019Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING CASE THE LIP ON THE END OF THE T2 SHORT SELF HOLDING SCREWDRIVER WHICH HOLDS THE SCREW IN, BROKE OFF. IT IS UNKNOWN ON INTAKE WHETHER ANY UNINTENDED METAL FELL INTO THE PATIENT. BOTH SCREW DRIVERS GOT DAMAGED AT THE SAME CASE. 20TH FEB. WAS THE OP DATE. THERE WERE NO DAMAGED ITEMS IN THE PATIENT ACCORDING TO HIM. THERE WERE NO DELAYS TO THE OPERATION AS THERE ARE SPARE STANDARD SCREWS DRIVERS IN THE SET WHICH CAN ALSO BE USED INSTEAD OF THE SELF-HOLDING SCREW DRIVERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445011 ↗
• MalfunctionMay 2, 2018Break

  AS REPORTED BY REP: "CHECKING INSTRUMENT BEFORE ASSEMBLY POST CASE AND NOTICED TIP OF SCREWDRIVER WAS BROKEN. THE SCREWDRIVER WAS NOT USED IN SURGERY, SO PATIENT WAS NOT AFFECTED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481130 ↗