AXSOS 702753Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07613327005028), received between Aug 31, 2015 and Jun 22, 2022 — classified as 1 injury, 56 malfunctions.

The most frequently reported specific device problem is “Fracture” (42 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE LOCKING SCREW WAS INSERTED ALL THE WAY TO THE END WITH A POWER TOOL, RESULTING IN EXCESSIVE TORQUE ON THE SCREWDRIVER AND THE DRIVER BIT BROKE OFF. ALL DEBRIS WAS REMOVED FROM THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776531 ↗
• MalfunctionJun 15, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BIT BROKE OFF. THE SURGEON TURNED THE SCREWDRIVER UNTIL LOCKING WITH A POWER TOOL, AND WHEN HE MANUALLY REVERSED THE ROTATION, IT WAS DAMAGED. ALL DEBRIS WAS REMOVED FROM THE AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14699611 ↗
• MalfunctionMay 23, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PLANNED AXSOS PLT EXTRACTION, THE SCREW WAS EXTRACTED SLIGHTLY BY HAND AND THEN ATTEMPTED TO BE EXTRACTED WITH AN ELECTRIC DRILL, BUT IT WAS FORWARDED, CAUSING THE LOCKING SCREW STUCK TO THE PLATE. THE SUBSEQUENT ATTEMPT TO REMOVE IT WAS TOO HARD AND THE TIPS OF TWO SCREWDRIVERS WERE BROKEN. A T10 SCREWDRIVER PREPARED FOR OTHER CASES WAS USED TO REMOVE, BUT ALSO WAS BROKEN. AFTER THAT, EXTRACTION WAS COMPLETED USING A CARBIDE DRILL AND CROWN DRILL. ALL DEBRIS WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14477402 ↗
• MalfunctionMay 23, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PLANNED AXSOS PLT EXTRACTION, THE SCREW WAS EXTRACTED SLIGHTLY BY HAND AND THEN ATTEMPTED TO BE EXTRACTED WITH AN ELECTRIC DRILL, BUT IT WAS FORWARDED, CAUSING THE LOCKING SCREW STUCK TO THE PLATE. THE SUBSEQUENT ATTEMPT TO REMOVE IT WAS TOO HARD AND THE TIPS OF TWO SCREWDRIVERS WERE BROKEN. A T10 SCREWDRIVER PREPARED FOR OTHER CASES WAS USED TO REMOVE, BUT ALSO WAS BROKEN. AFTER THAT, EXTRACTION WAS COMPLETED USING A CARBIDE DRILL AND CROWN DRILL. ALL DEBRIS WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14477105 ↗
• MalfunctionMay 5, 2022Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT WHEN THE SCREW WAS INSERTED, WITH A SCREWDRIVER ATTACHED TO THE HANDPIECE, THE SCREWDRIVER TIP WAS DAMAGED DUE TO OVERTIGHTENING. ADDITIONALLY THE SCREWDRIVER WAS BROKEN, THE DEBRIS WAS REPORTED AND ALL THE DEBRIS WAS REMOVED FROM THE PATIENT. THIS EVENT HAPPENED DURING A PRIMARY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287039 ↗
• MalfunctionApr 19, 2022Break; Fracture; Break; Fracture

  SCREWS WERE INSERTED USING A HANDPIECE. THE SCREWDRIVER BIT BROKE OFF BECAUSE THE HANDPIECE CONTINUED TO ROTATE WITHOUT STOPPING BEFORE THE FINAL TIGHTENING OF THE SCREW. NO DEBRIS HAVE BEEN LEFT IN THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147679 ↗
• MalfunctionMar 19, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN INSERTING THE LOCKING SCREW, THE SURGEON ATTACHED THE SCREWDRIVER BIT TO THE POWER TOOL AND INSERTED THE SCREW. THE PLAN WAS TO REPLACE THE POWER TOOL WITH A MANUAL SCREWDRIVER HANDLE JUST BEFORE LOCKING, BUT HE INSERTED IT WITH POWER TOOL UNTIL IT LOCKED, AND THE TIP OF THE SCREWDRIVER BIT WAS TWISTED OFF. THE TIP OF THE SCREWDRIVER IS REMAINED TO THE SCREW HEAD."

  Patient problems: Foreign Body In Patient

  MAUDE report 13826668 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  DURING REMOVAL OF THE AXSOS LOCKING SCREWS, TWO SCREWDRIVERS WERE BROKEN OFF AT THE TIPS. WHEN THE HANDPIECE WAS USED FOR SCREW REMOVAL, THE SURGEON MISTAKENLY TURNED IT IN POSITIVE ROTATION. AT THAT TIME, A TORQUE WAS APPLIED AND ONE OF THE SCREWDRIVERS WAS BROKEN. THE SURGEON THEN TRIED TO REMOVE IT BY HAND, BUT ONE OTHER SCREWDRIVER ALSO BROKE OFF. AFTER THAT, THE SURGEON USED A SCREWDRIVER OF THE SAME STANDARD FROM ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552999 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  DURING REMOVAL OF THE AXSOS LOCKING SCREWS, TWO SCREWDRIVERS WERE BROKEN OFF AT THE TIPS. WHEN THE HANDPIECE WAS USED FOR SCREW REMOVAL, THE SURGEON MISTAKENLY TURNED IT IN POSITIVE ROTATION. AT THAT TIME, A TORQUE WAS APPLIED AND ONE OF THE SCREWDRIVERS WAS BROKEN. THE SURGEON THEN TRIED TO REMOVE IT BY HAND, BUT ONE OTHER SCREWDRIVER ALSO BROKE OFF. AFTER THAT, THE SURGEON USED A SCREWDRIVER OF THE SAME STANDARD FROM ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552997 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  DURING REMOVAL OF AXSOSPLT AFTER BONE FUSION, ONE SCREW WAS OVERTIGHTENED AND TWO SCREWDRIVERS WERE BROKE OFF. REMOVAL WAS PERFORMED USING A HOSPITAL-OWNED RESCUE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552467 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING REMOVAL OF AXSOSPLT AFTER BONE FUSION, ONE SCREW WAS OVERTIGHTENED AND TWO SCREWDRIVERS WERE BROKE OFF. REMOVAL WAS PERFORMED USING A HOSPITAL-OWNED RESCUE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552454 ↗
• MalfunctionFeb 10, 2022Break; Fracture; Break; Fracture

  AS REPORTED; "THE TIP OF THE SCREWDRIVER WAS BROKE OFF DURING THE AXSOS PLATE REMOVAL SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509870 ↗
• MalfunctionJan 19, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE SCREWDRIVER TIP WAS DAMAGED DURING SCREW REMOVAL.THE SURGEON VISUALLY AND RADIOGRAPHICALLY CONFIRMED THAT THERE WAS NO REMAINING OF THE DAMAGED MATERIAL IN THE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289508 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED: "THE TIP OF THE SCREWDRIVER WAS CHIPPED DURING THE REMOVAL SURGERY AFTER BONE HEALING. THE TIP OF THE SCREWDRIVER WAS DEFEATED BY THE STRONG FORCE. ON 12/16/2021 - ADDITIONAL INFORMATION RECEIVED: THE TIP OF THE SCREWDRIVER WAS NOT LEFT IN PATIENT¿S BODY AND THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13067181 ↗
• MalfunctionMay 3, 2021Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THERE WAS DIFFICULTY INSERTING THE SCREW DUE TO ARTIFICIAL BONE OBSTRUCTION. THE USER ATTEMPTED TO INSERT THE SCREW BY POWER DRIVER, BUT THE SCREWDRIVER BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11767592 ↗
• MalfunctionApr 1, 2021Break; Material Deformation; Break; Material Deformation

  AS REPORTED: "THE TIPS OF 2 SCREWDRIVERS WERE DAMAGED WHEN THE PROXIMAL PLATE OF THE AXOS TIBIA WAS PULLED OUT. THE SCREW WAS ABLE TO REMOVED WITH A DRIVER OF THE SAME STANDARD OF OTHER COMPANY IN THE DEFORMATION OF THE SCREW COULD NOT BE CONFIRMED IN THE PHOTO BEFORE REMOVAL. IT WAS CONFIRMED NO RESIDUAL REMAINED INSIDE THE BODY. THE CATALOG NO. OF SCREW IS UNKNOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602880 ↗
• MalfunctionApr 1, 2021Break; Material Deformation; Break; Material Deformation

  AS REPORTED: "THE TIPS OF 2 SCREWDRIVERS WERE DAMAGED WHEN THE PROXIMAL PLATE OF THE AXOS TIBIA WAS PULLED OUT. THE SCREW WAS ABLE TO REMOVED WITH A DRIVER OF THE SAME STANDARD OF OTHER COMPANY IN THE DEFORMATION OF THE SCREW COULD NOT BE CONFIRMED IN THE PHOTO BEFORE REMOVAL. IT WAS CONFIRMED NO RESIDUAL REMAINED INSIDE THE BODY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602497 ↗
• InjuryMar 22, 2021Fracture; Fracture

  AS REPORTED: THE CUSTOMER REPORTED THAT : "DURING AN ABLATION OF THE SCREW, THE HEAD OF THE SCREWDRIVER REF 702753 BROKE (AXOS). USE OF OUR MATERIAL, REMOVAL OF THE SCREW, WITHOUT SUCCESS. IMPLANTATION OF THE PLATE IN 2019 IN GAP (OTHER ESTABLISHMENT) : TIBIAL PLATE (RIGHT) NOT REMOVED: GENERAL ANESTHESIA WASTED 2 SCREWS ARE COMPLETELY LOCKED IN THE PLATE (UPPER SCREWS) A SECOND ANESTHESIA WILL BE REQUIRED". THE OSTEOSYNTHESIS MATERIAL WAS LEFT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11548343 ↗
• MalfunctionMar 18, 2021Fracture; Fracture

  AS REPORTED: "DURING THE REMOVAL OPERATION OF THE PROXIMAL HUMERUS PLATE OF AXOS, THE LOCKING SCREW WAS HARD AND THE TIP OF THE SCREWDRIVER WAS BROKEN, AND THE BROKEN SCREWDRIVER TIP GOT STUCK IN THE SCREW HEAD. AFTER REMOVING ALL THE OTHER SCREWS, THE SURGEON SCRAPED IT WITH AN AIR TOME ETC. AND COMPLETED REMOVING ALL THE IMPLANTS. THERE IS NO RESIDUE INSIDE THE BODY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517743 ↗
• MalfunctionDec 12, 2020Fracture; Fracture

  AS REPORTED: "THE PLATE COULD NOT BE REMOVED FROM THE SCREW AND THE PLATE COULD NOT BE REMOVED. THE DRILL BROKE WHEN THE SCREW WAS REMOVED, BUT THERE WAS NO RESIDUE INSIDE THE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10996119 ↗
• MalfunctionNov 16, 2020Fracture; Fracture

  AS REPORTED: "THE PLATE COULD NOT BE REMOVED FROM THE SCREW AND THE PLATE COULD NOT BE REMOVED. THE DRILL BROKE WHEN THE SCREW WAS REMOVED, BUT THERE WAS NO RESIDUE INSIDE THE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844936 ↗
• MalfunctionNov 13, 2020Fracture; Fracture

  AS REPORTED: "TIBIAL PROXIMAL ORIF. REMOVED AXSOS PT. THE SCREW ON THE JOINT SURFACE DID NOT COME OFF, AND TWO SCREWDRIVER TIPS BROKE. AFTER CUTTING THE TIP OF THE SCREW WITH A CARBIDE, I SCRAPED THE CIRCUMFERENCE A LITTLE LARGER AND MANAGED TO REMOVE IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840336 ↗
• MalfunctionNov 13, 2020Fracture; Fracture

  AS REPORTED: "TIBIAL PROXIMAL ORIF. REMOVED AXSOS PT. THE SCREW ON THE JOINT SURFACE DID NOT COME OFF, AND TWO SCREWDRIVER TIPS BROKE. AFTER CUTTING THE TIP OF THE SCREW WITH A CARBIDE, I SCRAPED THE CIRCUMFERENCE A LITTLE LARGER AND MANAGED TO REMOVE IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840321 ↗
• MalfunctionSep 10, 2020Fracture; Fracture

  AS REPORTED: "AXSOS TIBIAL SCREW REMOVAL SURGERY. ONE SCREW DID NOT TURN AT ALL. TWO DRIVER BITS WERE BROKEN. THE SCREW HEAD WAS DUG OUT WITH A CARBIDE DRILL. THE REMAINING SCREWS WERE REMOVED WITH A HOSPITAL-OWNED DRIVER (T15)."

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

  MAUDE report 10517074 ↗
• MalfunctionSep 10, 2020Fracture; Fracture

  AS REPORTED: "AXSOS TIBIAL SCREW REMOVAL SURGERY. ONE SCREW DID NOT TURN AT ALL. TWO DRIVER BITS WERE BROKEN. THE SCREW HEAD WAS DUG OUT WITH A CARBIDE DRILL. THE REMAINING SCREWS WERE REMOVED WITH A HOSPITAL-OWNED DRIVER (T15)."

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

  MAUDE report 10516682 ↗