AXSOS 702747Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327005011), received between Sep 25, 2015 and Jun 9, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT TWO SCREWDRIVERS WERE DAMAGED IN THIS SET WHILST BEING USED IN THEATRE. UPON RECEIPT OF THE DEVICES, THE TIP WAS FOUND TO BE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 17097518 ↗
• MalfunctionJun 3, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DAMAGED WRENCH DURING THE PROCEDURE IN THE PLACEMENT OF THE SCREW, BREAKING THE TIP IN THE TIGHTENING OF THE SCREW."

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

  MAUDE report 14592672 ↗
• MalfunctionApr 14, 2021Break; Break

  AS REPORTED: "STRYKER REP REPORTED A BROKEN SCREWDRIVER. SURGEON HAD TO REMOVE OLD IMPLANTS FROM PATIENT¿S ANKLE. WAS ABLE TO REMOVE MOST OF THE SCREWS BUT SCREWDRIVER HEAD SHEARED OFF WHILE ATTEMPTING TO REMOVE ANOTHER SCREW. PROCEDURE SUCCESSFULLY COMPLETED, SURGEON HAD TO USE OTHER METHOD TO RETRIEVE THE REST OF THE SCREWS. NO NEED FOR ADDITIONAL MEDICAL INTERVENTION, ONLY LENGTHENED PROCEDURE TIME".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668917 ↗
• MalfunctionDec 2, 2019Fracture; Fracture

  A DOCTOR WROTE A LETTER, IN WHICH SHE SAID : "STRYKER SCREWDRIVERS SHOULD BE DECLARED IN MATERIAL VIGILANCE FOR AXSOS EQUIPMENT. BOTH THE HANDLE SCREWDRIVERS AND THE AO QUICK-RELEASE SCREWDRIVERS BREAK WHEN REMOVING SOME SCREWS THAT ARE TOO TIGHT AND IT IS IMPOSSIBLE TO REMOVE THE SCREWS WITHOUT DESTROYING THE SCREW HEAD. A PATIENT FROM NORTHERN FRANCE WAS ENTRUSTED TO ME FOR AN EQUIPMENT REMOVAL, THE SURGEON HAD BROKEN THE ONLY AXSOS SCREWDRIVER HE HAD. WHEN I REMOVED THIS PATIENT'S EQUIPMENT, I BROKE 2 SCREWDRIVERS MYSELF ABOUT A MONTH AGO. FOR THIS LAST INTERVENTION YESTERDAY, [...] I BROKE 3 SCREWDRIVERS OF THE SAME BRAND FOR THE SAME TYPE OF MATERIAL DEVICE. THE FACT OF HAVING DESTROYED THE SCREW HEADS TO REMOVE THE MATERIAL LENGTHENS THE OPERATING TIME SO THE RISK OF INFECTION BECOMES MAJOR, MULTIPLE METALLIC FOREIGN BODIES ARE SCATTERED, WHILE WITH STRONGER SCREWDRIVERS THERE WOULD BE NO PARTICULAR PROBLEM" ADDITIONAL INFORMATION REPORTED: "THE BREAKAGE OF THESE UNSTABLE SCREWDRIVERS SEEMS TO US TO OCCUR DURING THE REMOVAL OF THE TITANIUM TORX SCREWS, EVEN THOUGH THEY WERE INSTALLED WITH A TORQUE SCREWDRIVER. NOTE THAT THERE IS NO BREAKAGE DURING INSTALLATION, BUT WHEN REMOV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397967 ↗
• MalfunctionDec 2, 2019Fracture; Fracture

  A DOCTOR WROTE A LETTER, IN WHICH SHE SAID : "STRYKER SCREWDRIVERS SHOULD BE DECLARED IN MATERIAL VIGILANCE FOR AXSOS EQUIPMENT. BOTH THE HANDLE SCREWDRIVERS AND THE AO QUICK-RELEASE SCREWDRIVERS BREAK WHEN REMOVING SOME SCREWS THAT ARE TOO TIGHT AND IT IS IMPOSSIBLE TO REMOVE THE SCREWS WITHOUT DESTROYING THE SCREW HEAD. -A PATIENT FROM NORTHERN FRANCE WAS ENTRUSTED TO ME FOR AN EQUIPMENT REMOVAL, THE SURGEON HAD BROKEN THE ONLY AXSOS SCREWDRIVER HE HAD. -WHEN I REMOVED THIS PATIENT'S EQUIPMENT, I BROKE 2 SCREWDRIVERS MYSELF ABOUT A MONTH AGO. -FOR THIS LAST INTERVENTION YESTERDAY, [...] I BROKE 3 SCREWDRIVERS OF THE SAME BRAND FOR THE SAME TYPE OF MATERIAL DEVICE. THE FACT OF HAVING DESTROYED THE SCREW HEADS TO REMOVE THE MATERIAL LENGTHENS THE OPERATING TIME SO THE RISK OF INFECTION BECOMES MAJOR, MULTIPLE METALLIC FOREIGN BODIES ARE SCATTERED, WHILE WITH STRONGER SCREWDRIVERS THERE WOULD BE NO PARTICULAR PROBLEM" ADDITIONAL INFORMATION REPORTED: "THE BREAKAGE OF THESE UNSTABLE SCREWDRIVERS SEEMS TO US TO OCCUR DURING THE REMOVAL OF THE TITANIUM TORX SCREWS, EVEN THOUGH THEY WERE INSTALLED WITH A TORQUE SCREWDRIVER. NOTE THAT THERE IS NO BREAKAGE DURING INSTALLATION, BUT WHEN RE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397805 ↗
• MalfunctionSep 17, 2018Break

  PRODUCT WAS RETURNED TO STRYKER (B)(4) TECHNICAL SERVICES FOR REPAIR ALONG WITH OTHER PRODUCTS. THE PRODUCT WAS NOTICED TO HAVE A BROKEN/SHEARED BIT AT THE SCREWDRIVER TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7883154 ↗
• MalfunctionSep 25, 2015Break

  IT WAS REPORTED THAT DURING THE REMOVAL OF A SCREW, THE HEAD OF THE SCREWDRIVER BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5104247 ↗