FIXOS 705212Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613252708469), received between Nov 30, 2017 and Jul 20, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25881301 ↗
• MalfunctionFeb 21, 2026Fracture

  AS REPORTED: ¿THE HEAD OF THE T30 SCREWDRIVER BROKE WHILE THE SURGEON WAS TIGHTENING THE FIXOS SCREW.¿ THE DEVICE IS BROKEN HOWEVER ALL DEBRIS WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410323 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

  AS REPORTED: "SCREWDRIVER HAS BROKEN. SPARE DEVICE WAS AVAILABLE AND USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801758 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CANNULATED DRIVER BROKE ON THE THREADING AND THE PATIENT HAD TO BE OPENED UP TO FIND THE BROKEN PIECE. THE PROCEDURE TIME WAS EXTENDED AND COMPLETED USING A SECOND CANNULATED DRIVER, ON POWER AND BY HAND, SWITCHING IT BACK AND FORTH. THE SURGEON HAD TO OPEN THE PATIENT UP A BIT FURTHER TO FIND THE MISSING PIECE THAT WAS STUCK ON THE GUIDE WIRE, AND THE SURGERY WENT A BIT LONGER THAN ANTICIPATED. OTHERWISE, NO FURTHER COMPLICATIONS WERE EXPERIENCED. ALL DEBRIS WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 23596413 ↗
• MalfunctionNov 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT "TWO SCREWDRIVER BLADES BROKE NEAR THE TIP DURING THE INSERTION OF A SCREW. REPLACEMENT DEVICE (SCREWDRIVER BLADE) WAS AVAILABLE AND USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583449 ↗
• MalfunctionNov 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT "TWO SCREWDRIVER BLADES BROKE NEAR THE TIP DURING THE INSERTION OF A SCREW. REPLACEMENT DEVICE (SCREWDRIVER BLADE) WAS AVAILABLE AND USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582486 ↗
• MalfunctionSep 23, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "FIXOS SCREW DRIVER BROKE. ALL DEBRIS REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23128290 ↗
• MalfunctionJul 21, 2025Break; Fracture; Break; Fracture

  AS REPORTED: ''SURGEON REPORTS ON THE BREAKAGE OF A TORX 30 SCREWDRIVER (CANNULATED) FROM THE FIXOS NG 7.0 MM SCREW SYSTEM, NON-CANNULATED SCREWDRIVER FROM THE SURGICAL TRAY WAS USED TO COMPLETE THE PROCEDURE, THE ARTICLE IS 1 YEAR OLD AND HAS BEEN STERILIZED 20 TIMES''.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554758 ↗
• MalfunctionJul 11, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE SURGEON THAT A TORX 30 SCREWDRIVER (CANNULATED), FROM THE FIXOS 7.0 MM SCREW SYSTEM BROKE INTRAOPERATIVELY. ANOTHER SCREW DRIVER WAS TAKEN FROM THE OP TRAY.THE ARTICLE IS 2 MONTHS OLD AND IT HAS BEEN STERILIZED 3 TIMES. THERE WAS NO DEBRIS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479169 ↗
• MalfunctionJun 6, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BIT BROKE OFF ON THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158753 ↗
• InjuryJun 4, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT: "DURING THE EXECUTION OF A SURGICAL PROCEDURE OF "FUSION OF THE SUBTALAR", ACCIDENTALLY, AT THE MOMENT OF THE INTRODUCTION OF THE SECOND FIXOS SCREW INTO THE CALCANEUS, DESPITE THE GUIDE WIRE, THE TIP OF THE INTRODUCER HANDPIECE BROKE. FOLLOWING THIS EVENT, A SMALL METAL SPLINTER REMAINED IN THE SOFT TISSUES THAT COULD NOT BE IDENTIFIED AND REMOVED. IMMEDIATELY, AN X-RAY OF THE FOOT WAS PERFORMED WHICH CONFIRMED THE PRESENCE OF THE SMALL FRAGMENT IN THE SOFT TISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY."

  Patient problems: Foreign Body In Patient

  MAUDE report 22142532 ↗
• MalfunctionApr 21, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON WAS IMPLANTING CANNULATED SCREWS FOR AND ANKLE FUSION. HE WAS IMPLANTING THEM BY HAND INTO THE PATIENT OVER THE 3.2MM GUIDE WIRE. THE TIP OF THE DRIVER BROKE OFF IN THE T30 STAR DRIVE RECESS FOR THE SCREW. THE FRAGMENT BECAME STUCK IN THE SCREW HEAD. USING KELLY CLAMPS, HE WAS ABLE TO PULL THE BROKEN PIECES OF THE DRIVER TIP OUT. WE THEN EXPLANTED THE SCREW TO EXAMINE IF THE SCREW HAD BECOME DAMAGED OR HAD ANY PIECE OF THE DRIVER LEFT IN IT, WE WERE ABLE TO REMOVE THE FRAGMENTED DRIVER TIP FROM THE PATIENT AND PATIENT WILL BE FINE. THIS INCREASED OPERATIVE TIME AS WE HAD TO SEARCH FOR AND REMOVE THE BROKEN PIECE OF THE DRIVER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876474 ↗
• MalfunctionApr 8, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON REPORTS A BREAKAGE OF THE TORX 30 SCREWDRIVER (CANNULATED) FROM THE FIXOS 7.0 MM SCREW SYSTEM, A SECOND SCREW DRIVER WAS USED FROM THE OP TRAY."A 30 MIN DELAY IN THE SURGERY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21799016 ↗
• MalfunctionMar 14, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON REPORTS A BREAKAGE OF THE TORX 30 SCREWDRIVER (CANNULATED) FROM THE FIXOS 7.0 MM SCREW SYSTEM. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610366 ↗
• InjuryJan 31, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "DURING THE SURGERY WHICH REQUIRED THE USE OF X1 FIXOS 7MM CANNULATED SCREW, DURING THE FINAL TIGHTENING OF THE SCREW, THE TIP OF THE T30 CANNULATED SCREWDRIVER BIT BROKE INTO PIECES. THE REMAINS OF THE SCREWDRIVER BIT IN THE HEAD OF THE CANNULATED SCREW HAD TO BE REMOVED BY THE SURGEON. DURING THE PROCEDURE, IT WAS VERY CLEAR THAT THE CANNULATED SCREWDRIVER BIT HAD BROKEN DURING THE FINAL TIGHTENING DUE TO SOUND AND MOVEMENT OF THE SURGEONS HAND, THE SURGEON REMOVED THE SCREWDRIVER FROM THE SCREW AND IT WAS CLEARLY VISIBLE THAT THE SCREWDRIVER BIT HAD BROKEN. THE SURGEON SEEMED OKAY WITH THE OVERALL RESULT. NO FURTHER INTERVENTION WAS PERFORMED TO INSERT THE SCREW ANY FURTHER AS IT WAS THE FINAL TIGHTENING WHEN THE SCREWDRIVER BIT BROKE. THE SURGEON DID HAVE TO REMOVE THE DEBRIS THAT WAS IN THE HEAD OF THE SCREW." THE PROCEDURE WAS DELAYED BY 10-15MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283998 ↗
• MalfunctionJan 23, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE T30 SCREWDRIVER TIP WAS DAMAGED AND BROKE. IT WAS ALSO REPORTED THAT THE PATIENT HAD VERY HARD BONE. A DIFFERENT SCREWDRIVER TIP WAS USED TO COMPLETE THE SURGERY AND ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD/PATIENT. THE TRACKING NUMBER WAS PROVIDED FOR THE PRODUCT RETURN AND NO FURTHER INFORMATION WAS PROVIDED REGARDING THE USE HISTORY OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217830 ↗
• InjuryDec 4, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRIVER BROKE WITHIN THE SCREW, AND SURGEON REMOVED THE BITS OF DRIVER PIECE BY PIECE WITH IRRIGATION AND FORCEPS. MOST OF DEBRIS WERE REMOVED. DRIVER PIECE IS STILL IN SCREW HEAD AND COULD NOT BE REMOVED." THE PROCEDURE WAS DELAYED BY 20 MIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20842825 ↗
• MalfunctionOct 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED; "DURING THE PROCEDURE, THE SURGEON UTILIZED FIXOS 7.0 CANNULATED SCREWS IN ACCORDANCE WITH THE STANDARD SURGICAL TECHNIQUE. WHILE INSERTING THE FINAL SCREW, THE TIP OF THE SCREWDRIVER (705212) BROKE WITHIN THE SCREW'S DRIVE. IT WAS OBSERVED THAT THE PATIENT'S BONE WAS HARDER THAN USUAL, NECESSITATING INCREASED FORCE DURING SCREW IMPLANTATION. THE PROCEDURE PROCEEDED WITHOUT DELAY, AS A SECOND CANNULATED SCREWDRIVER BIT (705212) WAS AVAILABLE IN THE SURGICAL TRAY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467538 ↗
• MalfunctionJun 13, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT TWO SCREWDRIVERS BROKE OFF DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527143 ↗
• MalfunctionJun 13, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT TWO SCREWDRIVERS BROKE OFF DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527142 ↗
• MalfunctionNov 14, 2023

  LOANER SCREW SET USED FOR HARDWARE REMOVAL. SURGEON ATTEMPTED TO REMOVE OLD HARDWARE WITH APPROPRIATE SCREWDRIVER FOR THE PREVIOUSLY IMPLANTED SCREW. THE SCREWDRIVER BROKE IN THE ATTEMPT. THE SURGEON REMOVED PIECES AND COULD SEE WITH ROOM XRAY NOTHING WAS REMAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130396 ↗
• MalfunctionAug 22, 2019Break

  IT WAS REPORTED THAT DURING A FOOT & ANKLE PROCEDURE, THE SCREWDRIVER BROKE WHILE IMPLANTING THE CANNULATED COMPRESSION SCREW. ANOTHER SCREWDRIVER WHICH WAS IMMEDIATELY AVAILABLE IN THE O.R. WAS USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO DELAY. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8922756 ↗
• MalfunctionMar 28, 2019Break; Fracture; Fracture

  TIP OF SCREWDRIVER BROKE DURING INSERTION OF SCREW. ONE FRAGMENT FROM THE SCREW DRIVER WAS INSIDE THE SCREW, SO THE SCREW HAD TO BE REPLACED; DELAY OF APPROXIMATE 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461805 ↗
• MalfunctionJun 25, 2018Break

  BROKEN PIN FOUND IN RETURN LOAN SET FROM CUSTOMER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635279 ↗
• MalfunctionNov 30, 2017Break

  FIXOS 7.0 SCREWDRIVER TIP BROKE WHILE INSERTING SCREW BY HAND. INCREASED TOURNIQUET TIME DUE TO SWITCHING DRIVERS AND PICKING OUT BROKEN PIECES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073007 ↗