FIXOSRecalls & reported problems across all models
Stryker GmbH · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 12 models of FIXOS by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2016 and Jul 20, 2026 — classified as 11 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FIXOS problems
Device problems
- Fracture27
- Break23
- Biocompatibility3
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Material Fragmentation1
- Material Protrusion/Extrusion1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient7
- Foreign Body In Patient4
- Hypersensitivity/Allergic reaction3
- Implant Pain3
- Failure of Implant2
- Insufficient Information2
- Ambulation or Postural Difficulties1
FIXOS models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FIXOS 705212Screw, fixation, bone25 reports
- FIXOS 658042Screw, fixation, bone3 reports
- FIXOS CS24AScrew, fixation, bone2 reports
- FIXOS 705211Screw, fixation, bone2 reports
- FIXOS WS12Screw, fixation, bone1 report
- FIXOS CS36AScrew, fixation, bone1 report
- FIXOS HV20Screw, fixation, bone1 report
- FIXOS SV28Screw, fixation, bone1 report
- FIXOS WS13Screw, fixation, bone1 report
- FIXOS 658040Screw, fixation, bone1 report
- FIXOS 658046Screw, fixation, bone1 report
- FIXOS 940184Screw, fixation, bone1 report
Recent FIXOS adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 10, 2026Fracture
AS REPORTED: ¿BREAKAGE OF THE CANNULATED TORX 20 SCREWDRIVER FROM THE FIXOS 5.0 MM SCREW SYSTEM. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND SCREWDRIVER FROM THE INSTRUMENT TRAY.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559416 ↗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 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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