NA 45-20001Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04546540534385), received between Aug 20, 2015 and Oct 9, 2024 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Break; Fracture; Break; Fracture

  DURING PRIMARY SURGERY THE TIP OF SCREW DRIVER BROKEN OFF AND DEBRIS WERE MISSING. IT HAS BEEN CONFIRMED THAT NO DEBRIS WERE REMAIN IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412157 ↗
• MalfunctionNov 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED. "SCREWDRIVER TIP BROKE OFF WHILE TIGHTENING SCREW. (B)(6) 2023 - UPDATE. ENDS WITH THE SCREW HEAD JUST SLIGHTLY FLOATING OFF THE CORTICAL BONE. THERE IS A DAMAGED FRAGMENT THAT HAS NOT BEEN FOUND, SO IT IS POSSIBLE THAT IT REMAINS IN THE SCREW HEAD."

  Patient problems: Foreign Body In Patient

  MAUDE report 18241766 ↗
• MalfunctionFeb 28, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING SCREW INSERTION, THE SCREWDRIVER BROKE OFF. IT SEEMS THAT THE TORQUE WAS NOT APPLIED STRONGLY."

  Patient problems: Insufficient Information

  MAUDE report 16455809 ↗
• MalfunctionFeb 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE DRIVER WAS BROKEN." IT IS UNCLEAR IF THERE WAS ANY DEBRIS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16336337 ↗
• MalfunctionJan 10, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE SCREWDRIVER WAS FOUND TO BE BROKEN POSTOPERATIVELY. THE SURGERY WAS SUCCESSFULLY COMPLETED." IT IS UNCLEAR IF THERE WAS DEBRIS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16131349 ↗
• MalfunctionJan 10, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE DRIVER WAS BROKEN." IT IS UNCLEAR IF THERE WAS ANY DEBRIS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16129517 ↗
• MalfunctionApr 27, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS A BREAKAGE OF THE SCREWDRIVER TIP. ALL THE DEBRIS WAS REMOVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14220252 ↗
• MalfunctionMar 9, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED: THE SURGEON WAS TIGHTENING THE SCREW AND THE TIP OF THE SCREWDRIVER BROKE INTO THREE TINY PIECES BEFORE THE SCREW WAS FULLY SEATED. IT TOOK 30-40 MINUTES TO FISH OUT THE PIECES IN ORDER TO PUT A NEW SCREWDRIVER IN TO SEAT THE SCREW. CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13707127 ↗
• MalfunctionAug 13, 2021Fracture; Fracture

  IT WAS REPORTED THE SCREWDRIVER BIT BROKE OFF AT THE TIP WHEN SCREWING IN AN ASNISMICRO SCREW 2.0MM INSIDE THE SITUS. IT REMAINS UNKNOWN AT THIS TIME WHETHER REMNANTS OF THE BROKEN BIT REMAIN IN THE SURGICAL SITE. NO ADVERSE CONSEQUENCE OR CLINICALLY SIGNIFICANT SURGICAL DELAY WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ((B)(6)2021) INDICATE THAT NO DEBRIS WERE LEFT IN THE PATIENT'S BODY.

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

  MAUDE report 12320609 ↗
• MalfunctionMar 10, 2021Fracture; Fracture

  AS REPORTED: "DURING THE INITIAL OPERATION, THE DRIVER BROKE. THEREAFTER, THE PROCEDURE COMPLETED WITHOUT PROBLEM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457159 ↗
• MalfunctionJan 8, 2021Fracture; Fracture

  AS REPORTED: "THE PATIENT UNDERWENT ORIF PROCEDURE FOR HAND. THE SURGEON INSERTED THE SCREW AS USUAL, BUT IT WAS DIFFICULT TO INSERT. THEN, HE NOTICED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. HE REPLACED THE SCREWDRIVER AND TRIED TO REINSERT IT, BUT THE SECOND SCREWDRIVER BROKE AND THE SCREW ITSELF COULDN'T COME OUT OF THE GUIDE WIRE. THEREAFTER, THE PROCEDURE COMPLETED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143386 ↗
• MalfunctionJan 8, 2021Fracture; Fracture

  AS REPORTED: "THE PATIENT UNDERWENT ORIF PROCEDURE FOR HAND. THE SURGEON INSERTED THE SCREW AS USUAL, BUT IT WAS DIFFICULT TO INSERT. THEN, HE NOTICED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. HE REPLACED THE SCREWDRIVER AND TRIED TO REINSERT IT, BUT THE SECOND SCREWDRIVER BROKE AND THE SCREW ITSELF COULDN'T COME OUT OF THE GUIDE WIRE. THEREAFTER, THE PROCEDURE COMPLETED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143076 ↗
• MalfunctionJan 5, 2021Fracture; Fracture

  AS REPORTED: "BLADE BROKE WHILE TIGHTENING SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121283 ↗
• MalfunctionDec 28, 2020Fracture; Fracture

  AS REPORTED: "PROXIMAL FRACTURE OF THE LEFT HUMERUS. THE SCREWDRIVER BROKE DURING THE OPERATION, BUT THE DOCTOR DIDN'T NOTICE IT. AFTER THE OPERATION WAS COMPLETED, IT WAS CONFIRMED THAT THE DRIVER WAS BROKEN WHEN CLEANING THE INSTRUMENT. THE INSIDE OF THE PATIENT WAS EXAMINED, BUT NO DEBRIS WAS FOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076751 ↗
• MalfunctionDec 8, 2020Fracture; Fracture

  AS REPORTED: "AN ASNIS MICRO 2.0 SCREW WAS BEING INSERTED FOR AN AKIN OSTEOTOMY AND THE SCREWDRIVER TIP BROKE OFF IN THE SCREW. THE CORRECT K-WIRE WAS INSERTED, X-RAY WAS TAKEN, DEPTH WAS MEASURED, CANNULATED DRILL WAS USED. THE DOCTOR WAS ABLE TO REMOVE THE PIECE OF THE SCREWDRIVER THAT BROKE OFF BY PULLING THE K-WIRE OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972193 ↗
• MalfunctionOct 23, 2020Fracture; Fracture

  AS REPORTED: "THE EVENT OCCURRED DURING THE OPERATION USING AZNIS MICRO 2.0. THE SCREWDRIVER TIP WAS DAMAGED WHEN THE SCREW WAS INSERTED WITHOUT PRE-DRILLING. THE DAMAGED DRIVER WAS RECOVERED. IT IS UNKNOWN WHETHER THERE ARE OTHER FINE FRAGMENTS, BUT WHEN CONFIRMED WITH A C-ARM AND X-RAY, THERE WAS NO FRAGMENTS IN THE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10726209 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED: THE TIP OF THE CANNULATED SCREW DRIVER BROKE WHILE IMPLANTING A SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10206528 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO REPLACE THE SCREW ONCE INSERTED, THE DRIVER WAS DAMAGED WHILE REMOVING THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10146177 ↗
• MalfunctionMar 27, 2020Fracture; Fracture

  IT WAS REPORTED: TIP OF SCREWDRIVER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9891716 ↗
• MalfunctionMar 16, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT FOOT. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE IN THE CANNULATED SCREW WHILE IMPLANTING. THE SCREW WAS REMOVED AND ANOTHER SCREW WAS IMPLANTED. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9837348 ↗
• MalfunctionJan 14, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT CONDYLE FRACTURE OF 1ST METATARSAL (GREAT TOE). IT WAS REPORTED THAT THE TIP OF THE CANNULATED DRIVER BROKE OFF IN THE SCREW. THE BROKEN TIP WAS REMOVED USING A PICK-UP, THE WIRE REMOVED, AND A SOLID DRIVER USED TO REMOVE THE SCREW. FRACTURE WAS ADDRESSED USING A 3.0 WIRE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1-2 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9587949 ↗
• MalfunctionAug 27, 2019Break

  AS REPORTED: "BROKEN TIP OF THE DRIVER WHEN INSERTING THE SCREW. THE BROKEN PART REMAINED IN THE BODY AND REMOVED IT ABOUT 1 HOUR FOR EXTRACTION. THERE IS ALSO A POSSIBILITY THAT REMAINS EVEN IN THE ROENTGEN CONFIRMATION."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935582 ↗
• MalfunctionJul 29, 2019Fracture; Break; Fracture

  BREAKAGE OF THE CANULLATED SCREWDRIVER. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8838006 ↗
• MalfunctionJul 29, 2019Fracture; Break; Fracture

  BREAKAGE OF THE CANULLATED SCREWDRIVER. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837920 ↗
• MalfunctionJul 18, 2019Fracture; Break; Fracture

  IT WAS REPORTED THAT WHEN THE 2.0 ASNIS MIRCRO CANNULATED SCREW DRIVER WAS ADVANCED OVER GUIDE WIRE, THE TIP OF THE DRIVER WAS BROKEN. THEREFORE, IT WAS CHANGED THE NEW SAME ONES, BUT SAME EVENT WAS OCCURRED. FINALLY, THE SCREW WAS IMPLANTED WITH SOLID DRILL. THE BROKEN PIECE OF THE DRIVER WAS REMOVED FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804440 ↗