AXSOS 702748Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540713711), received between Aug 18, 2015 and May 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "WE HAVE HAD AN INCIDENT WHERE TWO SCREWDRIVERS/HEADS HAVE SHEARED OFF DURING USE."

  Patient problems: Insufficient Information

  MAUDE report 21995486 ↗
• MalfunctionMar 26, 2021Fracture; Fracture

  "THE CUSTOMER REPORTED THAT DURING A FEMORAL PLATING SURGERY, TWO SCREWDRIVERS BROKE INTRA OP WHILE ATTEMPTING TO EXTRACT A LOCKING SCREW PREVIOUSLY INSERTED TO CHANGE HIS POSITION. ADDITIONAL INFORMATION: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE LOCKING SCREW INVOLVED IN THE EVENT HAS SUCCESSFULLY BEEN IMPLANTED. THE SURGEON DID NOT APPLIED PRESSURE AND DID NOT WORKED AT AN EXTREME ANGLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575723 ↗
• MalfunctionAug 12, 2020Fracture; Fracture

  AS REPORTED: " THE DOCTOR WAS USING A T20 SCREWDRIVER (703539) TO REMOVE A LOCKING SCREW AND REPLACE IT WITH A DIFFERENT LENGTH. THE SCREW WAS TIGHT, AS THE DOCTOR APPLIED MORE TORQUE TO THE SCREWDRIVER, THE TIP OF THE BLADE SNAPPED OFF. WE RECOVERED THE BROKEN PIECE AND NOTHING ADDITIONAL REMAINED IN THE PATIENT. ADDITIONALLY REPORTED FROM SALES REP, THE ACTUAL ITEM NUMBER FOR THE SCREWDRIVER IS 702748 WITH LOT N00517.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10399430 ↗
• MalfunctionSep 10, 2015Break

  IT WAS REPORTED THAT THE PRODUCT WAS RETURNED TO STRYKER (B)(4) WITH A NOTE FROM THE HOSPITAL ACCOUNT "BROKEN - TIP IN PATIENT". NO ADDITIONAL INFORMATION WAS PROVIDE BY THE CUSTOMER. FOLLOW UP WITH THE STRYKER SALES REP INDICATED THAT NO PRODUCT COMPLAINT/ISSUE HAD BEEN LOGGED BY THE CUSTOMER. NO INFORMATION ABOUT THE EVENT IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 5068710 ↗
• MalfunctionAug 18, 2015Break

  SCREWDRIVER WAS BROKEN DURING A SURGICAL PROCEDURE TO EXTRACT AXSOS 5.0. THIS OPERATION WAS THE FIRST WITH THIS INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5012018 ↗