AXSOS 703586Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540694089), received between May 22, 2018 and Jul 9, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764839 ↗
• MalfunctionApr 23, 2026Fracture

  AS REPORTED: "THE DRILL BIT BROKE. UPDATE MARCH 31, 2026 SCREWDRIVER WAS ADDED TO PRODUCT GRID. IT BROKE WHEN THE LOCKING SCREWS WERE TIGHTENED. IT WAS CONFIRMED THAT NEITHER PRODUCT REMAINED IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968232 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  AS REPORTED: "DRILL BIT BREAKAGE. WAS THERE ANY DEBRIS REPORTED? WERE THEY ALL REMOVED FROM THE SURGICAL FIELD/PATIENT? SOME FRAGMENTS WERE DAMAGED, BUT ALL WERE RECOVERED. FRAGMENTS WERE FOUND BUT ALL HAVE BEEN RECOVERED. HOW WAS THE EVENT RESOLVED? WHEN USING TWO PLATES, THE PLATE SCREWS WERE STRUCK AND DAMAGED. THE DAMAGE HAS BEEN REMOVED AND ADDRESSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633146 ↗
• MalfunctionMar 28, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL TRIP WAS BROKEN AND REMAINED TO PATIENT LEFT TIBIA DURING PROCEDURE. THERE WAS NO NEED TO REMOVE THE DRILL TIP AS THE PLATE WAS ALREADY IN PLACE. A NEW DRILL WAS USED FOR THE REMAINING SCREWS NEEDED AND A SCREW PLACED THROUGH A DIFFERENT HOLE IN THE PLATE."

  Patient problems: Foreign Body In Patient

  MAUDE report 16626753 ↗
• MalfunctionJan 23, 2023Break; Fracture; Break; Fracture

  AS REPORTED, "IN THE SURGERY IN WHICH TWO PLATES ARE PLACED ON THE PROXIMAL TIBIA, THE DRILL CONTACTED WITH A SCREW THAT HAD BEEN INSERTED EARLIER AND BROKE OFF. THE TIP OF THE DRILL WAS REMAINED TO THE PATIENT AND THE SURGERY WAS FINISHED."

  Patient problems: Foreign Body In Patient

  MAUDE report 16229247 ↗
• MalfunctionJul 19, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A DRILL BIT BROKE OFF IN BONE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059869 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A RIGHT PROXIMAL LATERAL TIBIAL PLATING PROCEDURE, THE TIPS OF 2 DRILL BITS BROKE OFF IN THE PATIENT'S BONE. THE TIPS WERE LEFT IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 11822413 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A RIGHT PROXIMAL LATERAL TIBIAL PLATING PROCEDURE, THE TIPS OF 2 DRILL BITS BROKE OFF IN THE PATIENT'S BONE. THE TIPS WERE LEFT IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 11815898 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED: THE TIP OF THE 2.5 DRILL BIT BROKE OFF AS IT ENCOUNTERED ANOTHER SCREW. THE 2.5 PERC DRILL BIT (703586) BROKE IN TIBIA WHILE DRILLING. SEVERAL HOLES WERE DRILLED SUCCESSFULLY IN THE TIBIA PRIOR THE EVENT. PATIENT HAD DECENTLY HARD BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT. TIPS OF DRILL BITS WERE LEFT IN PLACE AS RETRIEVAL WOULD HAVE POTENTIALLY CAUSED DAMAGE TO THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11750920 ↗
• MalfunctionMar 17, 2020Fracture; Fracture

  AS REPORTED IN FDA MEDWATCH REPORT # MW5092586: A (B)(6) Y/O MALE PT WAS TAKEN TO OPERATING ROOM ON (B)(6) 2022 FOR OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT TIBIAL PLATEAU FRACTURE. THE SURGEON ATTEMPTED TO DRILL CORTICAL SCREWS INTO THE TIBIAL PLATE DURING THE OPEN REDUCTION INTERNAL FIXATION WHEN TWO DRILL BITS WERE BROKEN OFF INTO THE BONE. SURGEON DETERMINED THAT ATTEMPTING TO RETRIEVE THE BROKEN FRAGMENTS WOULD CAUSE MORE HARM FOR THE BONE VERSUS LEAVING THEM IN PLACE AND THAT IT WOULD NOT AFTER THE PT'S OVERALL FUNCTION. SURGEON PROVIDED DISCLOSURE TO PT."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9845667 ↗
• MalfunctionMar 17, 2020Fracture; Fracture

  AS REPORTED IN FDA MEDWATCH REPORT # MW5092586: A (B)(6) Y/O MALE PT WAS TAKEN TO OPERATING ROOM ON (B)(6) 2022 FOR OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT TIBIAL PLATEAU FRACTURE. THE SURGEON ATTEMPTED TO DRILL CORTICAL SCREWS INTO THE TIBIAL PLATE DURING THE OPEN REDUCTION INTERNAL FIXATION WHEN TWO DRILL BITS WERE BROKEN OFF INTO THE BONE. SURGEON DETERMINED THAT ATTEMPTING TO RETRIEVE THE BROKEN FRAGMENTS WOULD CAUSE MORE HARM FOR THE BONE VERSUS LEAVING THEM IN PLACE AND THAT IT WOULD NOT AFTER THE PT'S OVERALL FUNCTION. SURGEON PROVIDED DISCLOSURE TO PT."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9845665 ↗
• MalfunctionFeb 19, 2020Fracture; Fracture

  IT WAS REPORTED THROUGH A MEDWATCH REPORT ((B)(4)): "WHILE PERFORMING A TIBIAL PLATEAU FRACTURE OPEN REDUCTION INTERNAL FIXATION, TWO DRILL BITS BROKE INSIDE THE PATIENT'S TIBIA. BROKEN DRILL BITS LEFT INSIDE THE PATIENT'S BONE AS IT WOULD REQUIRE SIGNIFICANT EFFORT AND LIKELY CAUSE MORE HARM TO REMOVE THEM."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9729560 ↗
• MalfunctionFeb 19, 2020Fracture; Fracture

  IT WAS REPORTED THROUGH A MEDWATCH REPORT ((B)(4)): "WHILE PERFORMING A TIBIAL PLATEAU FRACTURE OPEN REDUCTION INTERNAL FIXATION, TWO DRILL BITS BROKE INSIDE THE PATIENT'S TIBIA. BROKEN DRILL BITS LEFT INSIDE THE PATIENT'S BONE AS IT WOULD REQUIRE SIGNIFICANT EFFORT AND LIKELY CAUSE MORE HARM TO REMOVE THEM."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9729557 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT TIBIAL PLATEAU PROCEDURE, A DRILL BIT BROKE APPROXIMATELY HALFWAY THROUGH. A SECOND DRILL BIT WAS USED AND ALSO BROKE APPROXIMATELY HALFWAY THROUGH. THE BROKEN PORTION OF THE BITS IN THE PATIENT'S BONE WERE LEFT IN. THE TARGETER HAD TO BE REMOVED AND THE PROCEDURE CONTINUED PERCUTANEOUSLY WITHOUT THE TARGETER. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 35 TO 40 MINUTES. SURGEON REPORTED PATIENT'S BONE QUALITY AS AVERAGE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9604537 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT TIBIAL PLATEAU PROCEDURE, A DRILL BIT BROKE APPROXIMATELY HALFWAY THROUGH. A SECOND DRILL BIT WAS USED AND ALSO BROKE APPROXIMATELY HALFWAY THROUGH. THE BROKEN PORTION OF THE BITS IN THE PATIENT'S BONE WERE LEFT IN. THE TARGETER HAD TO BE REMOVED AND THE PROCEDURE CONTINUED PERCUTANEOUSLY WITHOUT THE TARGETER. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 35 TO 40 MINUTES. SURGEON REPORTED PATIENT'S BONE QUALITY AS AVERAGE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9604535 ↗
• MalfunctionJan 16, 2020Break

  WHILE PERFORMING A TIBIAL PLATEAU FRACTURE OPEN REDUCTION INTERNAL FIXATION, TWO DRILL BITS BROKE INSIDE THE PATIENT'S TIBIA. BROKEN DRILL BITS LEFT INSIDE THE PATIENT'S BONE AS IT WOULD REQUIRE SIGNIFICANT EFFORT AND LIKELY CAUSE MORE HARM TO REMOVE THEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9595683 ↗
• MalfunctionJul 18, 2019Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CALIBRATED DRILL BIT BROKE DURING THE OPERATION. THE TIP OF THIS DRILL IS TRAPPED IN THE PATIENT AND IT IS UNABLE TO BE TAKEN OUT. SURGICAL DELAY DUE TO 30 ATTEMPTS TO IT TAKE OUT. NO ADVERSE CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8804780 ↗
• MalfunctionApr 24, 2019Break; Detachment of Device or Device Component

  THE STRYKER REP PRESENT IN THE CASE REPORTED THAT DURING A PROXIMAL HUMERAL PLATING OF THE RIGHT HUMERUS, THE 2.5 MM DRILL BIT END BROKE OFF WHILE DRILLING THE BONE FOR A SCREW. THE BROKEN PART WAS LEFT IN THE VERY TIP OF THE FEMUR SHAFT, AS DECIDED BY THE SURGEON. A NEW DRILL FROM THE SET WAS GIVEN TO THE SURGEON TO COMPLETE THE PROCEDURE, SO MINIMAL DELAY TO THE PROCEDURE. UNINTENDED METAL LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8547117 ↗
• MalfunctionFeb 20, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE AXSOS TARGETING SYSTEM, THE DRILL BIT BROKE. IT WAS REPORTED THAT THE DRILL BIT TIP WAS LEFT IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8356335 ↗
• MalfunctionJan 17, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE AXSOS TARGETING SYSTEM, THE DRILL BIT BROKE. IT WAS REPORTED THAT IT BROKE RIGHT WHERE THE GOLD FLUTES OF THE DRILL MEET THE SOLID SILVER PORTION OF THE DRILL. IT WAS REPORTED THAT THE DRILL BIT TIP WAS LEFT IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8256885 ↗
• MalfunctionSep 5, 2018Break

  IT WAS REPORTED THAT WHEN THE DISTAL HOLE WAS DRILLING WITH DRILL (703586) AFTER PROXIMAL HOLE WAS DRILLING , TIP OF THE DRILL WAS BROKEN AND REMAINED IN THE PATIENT BONE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7848601 ↗
• MalfunctionJul 30, 2018Break

  DURING DRILLING TO FIX THE PROXIMAL OUTER PLATE OF THE AXOS TIBIA, THE DRILL BROKE IN CONTACT WITH THE SCREW. THE BROKEN TIP WAS INSIDE THE PATIENT'S TIBIA AND COULD NOT BE REMOVED. THE DOCTOR CONTINUED THE SURGERY TO COMPLETE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7732849 ↗
• MalfunctionMay 22, 2018Fracture

  THE CUSTOMER REPORTED THAT DURING AN AXSOS3 PROXIMAL LATERAL TIBIA PLATE THE SURGEON WAS USING THE DISTAL TARGETING INSTRUMENTS AND WHEN DRILLING FOR A CORTICAL SCREW IN THE SHAFT USING 2.5 DRILL CODE 703586, THE TIP OF THE DRILL SNAPPED. THE BROKEN PIECE HAS BEEN LEFT IN THE PATIENT MEANING THAT HOLE COULDN¿T BE USED. IT ONLY DELAYED SURGERY BY A MINUTE OR TWO AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7531697 ↗