AXSOS 705004Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327083606), received between Jun 17, 2019 and Jan 9, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Mechanical Jam

  AS REPORTED: "FOLLOWING DRILLING, THE DRILL SLEEVE AND DRILL BECAME STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DRILL AND SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028772 ↗
• MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE DRILL STUCK IN DRILL GUIDE WHILE DRILLING. IT IS NOT REMOVABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924909 ↗
• MalfunctionApr 19, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "WHEN DRILLING THROUGH THE LOCKING SLEEVE, AFTER DRILLING THE FRONT CORTEX, A STRANGE SOUND WAS HEARD AND THE DRILL COULD NOT BE PULLED OUT. WHEN THE ENTIRE SLEEVE WAS PULLED OUT, THE DRILL CAME OUT WITH IT, BUT THE DRILL COULD NOT BE PULLED OUT OF THE SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770417 ↗
• MalfunctionOct 25, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "INTERFERENCE WITH DRILL BIT WHEN USING LOCKING DRILL SLEEVES. THE SLEEVE WAS DAMAGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666321 ↗
• MalfunctionSep 29, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "DRILL STUCK IN SLEEVE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508002 ↗
• MalfunctionJun 29, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "WHEN DRILLING, A DRILL BIT GOT STUCK IN THE MIDDLE OF A DRILL SLEEVE AND COULD NEITHER BE ADVANCED NOR REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852168 ↗
• MalfunctionMar 16, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING AXSOS SURGERY, AFTER USING OSFERION FOR A PROXIMAL TIBIA FRACTURE, THE SLEEVE AND DRILL GOT STUCK WHEN DRILLING WITH A ROCKING DRILL. SPARE DRILL WAS USED AND THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789848 ↗
• MalfunctionNov 4, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE USING A PROXIMAL ROCKING DRILL, THE DRILL BIT BECAME STUCK IN THE SLEEVE AND COULD NOT BE INSERTED OR REMOVED ANY FURTHER. THE POWER TOOL WAS REPLACED WITH A HAND-CRANKED HANDLE, AND THE DRILL WAS REMOVED FROM THE SLEEVE BY REVERSE ROTATION. AFTER THAT, ANOTHER SLEEVE WAS CONNECTED TO THE PLATE, A NEW DRILL BIT WAS USED, AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750317 ↗
• MalfunctionAug 26, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED: "AXSOS-DT (ANTERIOR LATERAL) IS BEING USED FOR TIBIAL PILON FRACTURE. DURING THE FIRST DISTAL LOCKING DRILL, THE DRILL AND SLEEVE GOT STUCK . IT WAS TURNED IT TO PUSH THE DRILL FORWARD, BUT IT STUCK AND DID NOT PROCEED. ATTEMPTED TO REMOVE THE DRILL ONCE, BUT IT DID NOT ROTATE IN THE FORWARD ROTATION, SO WHEN TRIED TO REMOVE IT BY ROTATING IN THE REVERSE DIRECTION, THE SLEEVE ALSO ROTATED IN THE REVERSE DIRECTION AND CAME OFF THE PLATE. GRABBED THE SLEEVE WITH PLIERS AND SLOWLY ROTATED THE DRILL TO TRY TO PULL IT OUT, BUT IT DIDN'T COME OFF AT ALL. HE DECIDED THAT HE COULDN'T USE IT, SO HE OPENED ANOTHER NEW ONE AND CONTINUED THE OPERATION WITH ANOTHER SLEEVE. STILL THE SAME THING HAPPENED. HOWEVER, THIS TIME, PULLED IT OUT IMMEDIATELY, GRASPED THE SLEEVE WITH PLIERS, AND SLOWLY TURNED THE DRILL TO PULL IT OUT. IN THE SURGICAL FIELD, THE SLEEVE WAS DRILLED SEVERAL TIMES TO CONFIRM, AND THE OPERATION WAS CONTINUED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369746 ↗
• MalfunctionAug 24, 2021Mechanical Jam; Mechanical Jam

  THE FOLLOWING WAS REPORTED: AFTER TEMPORARILY FIXING THE PLATE WITH K WIRE, ONE CORTICAL SCREW WAS INSERTED TO THE DISTAL HOLE. AFTER THAT, WHEN THE SURGEON DRILLED TO INSERT THE LOCKING SCREW TO THE ANTERIOR PROXIMAL SCREW HOLE, THE DRILL HAS STOPPED WORKING INSIDE THE DRILL SLEEVE. THE DRILL DID NOT BE REMOVED BY ANY MEANS. FINALLY, THE SURGEON REMOVED THE SLEEVE AND DRILL TOGETHER WITH THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358168 ↗
• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN USING A STERILIZED DRILL THROUGH A SLEEVE, THE SLEEVE AND DRILL GOT STUCK. THE SURGEON OPENED THE SPARE DRILL TIP AND USED IT WITH ANOTHER SLEEVE, BUT THE SAME EVENT OCCURRED IN OTHER HOLE. AFTER THAT, THE SURGERY WAS COMPLETED USING A 3MM K WIRE AS A SUBSTITUTE AND A TAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280418 ↗
• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN USING A STERILIZED DRILL THROUGH A SLEEVE, THE SLEEVE AND DRILL GOT STUCK. THE SURGEON OPENED THE SPARE DRILL TIP AND USED IT WITH ANOTHER SLEEVE, BUT THE SAME EVENT OCCURRED IN OTHER HOLE. AFTER THAT, THE SURGERY WAS COMPLETED USING A 3MM K WIRE AS A SUBSTITUTE AND A TAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280415 ↗
• MalfunctionJul 29, 2021Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam

  AS REPORTED: "THE DRILL AND SLEEVE STUCK DURING DRILLING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246318 ↗
• MalfunctionJun 25, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING SURGERY, THE DRILL STUCK TO THE DRILL SLEEVE. ONCE THE SURGEON TOOK IT OUT OF THE PATIENT WITH THE SLEEVE, THE DRILL WAS BITING INTO THE SLEEVE. AFTER THAT, OTHER INSTRUMENTS WERE USED AND THE SURGERY WAS FINISHED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071675 ↗
• MalfunctionJun 7, 2021Mechanical Jam; Mechanical Jam

  THE FOLLOWING WAS REPORTED: WHEN USING THE AXSOS PROXIMAL LATERAL PLATE OF THE TIBIA , A DRILL SLEEVE WAS SET UP IN THE SCREW HOLE AND DRILLED WITH A LOCKING DRILL. IT WAS STICKING IN THE DRILL SLEEVE WITH STRANGE SOUNDS. USING A NEW DRILL AND SLEEVE, THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947186 ↗
• MalfunctionMar 30, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "DURING THE OPERATION, THE DRILL SLEEVE COULD NOT CONNECT TO THE PLATE. THE THREADED PART AT THE TIP OF THE SLEEVE WAS WORN OUT. IT WAS UNKNOWN WHETHER IT WAS WORN OUT DURING OR BEFORE SURGERY. THEREAFTER, THE PROCEDURE COMPLETED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593294 ↗
• MalfunctionJan 5, 2021Device Damaged by Another Device; Mechanical Jam; Device Damaged by Another Device; Mechanical Jam

  AS REPORTED: " THE DRILL BIT WAS CRIMPED TO THE DRILL SLEEVE DURING USE AND COULD NOT BE REMOVED. THE DRILL BIT WAS NEW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121225 ↗
• MalfunctionJun 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: WHEN ORIF PROCEDURE FOR THE DISTAL TIBIA WAS PERFORMED, AND AFTER TEMPORARILY FIXING THE PLATE WITH K WIRE, DRILLING WAS DONE USING A DRILL SLEEVE SHORT. BUT THE DRILL DID NOT COME OFF AND REMOVED TOGETHER WITH THE DRILL SLEEVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10158386 ↗
• MalfunctionJun 8, 2020Overheating of Device; Smoking; Noise, Audible; Difficult or Delayed Separation; Overheating of Device; Smoking; Noise, Audible; Difficult or Delayed Separation

  AS REPORTED: "WHEN I WAS USING THE 3.1 DRILL FOR THE AXSOS LOCKING SCREW, THERE WAS A STRANGE NOISE, HEAT, AND SMOKE. I TRIED TO REMOVE THE LOCKING SLEEVE, BUT IT WAS STUCK WITH THE TIP OF THE DRILL AND DID NOT COME OFF." ADDITIONALLY REPORTED: "SALINE WAS APPLIED TO COOL THE HEAT-GENERATING PART. REPLACED WITH ANOTHER DRILL TIP AND SLEEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10131027 ↗
• MalfunctionFeb 10, 2020Mechanical Jam; Mechanical Jam

  AS REPORTED: "DOCTOR WAS DRILLING THROUGH 4.0 LOCKING GUIDE WITH 3.1MM DRILL BIT AND NOTICED THE DRILL BIT WAS GETTING STUCK IN GUIDE. THE DOCTOR REMOVED THE GUIDE FROM THE PLATE AND TRIED TO PASS THE DRILL BIT THROUGH THE LOCKING GUIDE. THE DRILL BIT WOULDN'T PASS THROUGH THE LOCKING GUIDE. HE USED A DIFFERENT LOCKING GUIDE FROM THE AXSOS 3 4.0 TRAY AND CONTINUED THE SURGERY WITH NO ADVERSE EFFECTS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9689493 ↗
• MalfunctionAug 21, 2019Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE DRILL COLD WELDED WITH THE LOCKING DRILL GUIDE DURING THE PROCEDURE. THERE WAS A 5 MINUTE DELAY TO SURGERY. THE CUSTOMER FURTHER REPORTED THAT THE DRILL BIT DOESN'T ACTUALLY FIT THE SLEEVE/TOWER ON THE AXSOS 3 PLATING SYSTEM. AS A RESULT OF THIS MISMATCH, THE SURGEON BELIEVES THAT IT EXPLAINS WHY THE BIT BECOMING STUCK IN THE SLEEVE IF THE DIRECTION IS OFF BY A COUPLE OF DEGREES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8914882 ↗
• InjuryJul 17, 2019Entrapment of Device

  DURING AXSOS DT SURGERY, THE DRILL BIT STUCK INSIDE THE DRILL SLEEVE AFTER THE DRILLING. THE SURGEON REMOVED THE DRILL BIT FROM THE SLEEVE BY FORCE, SOFT TISSUE HAD BEEN ENTANGLED TO THE DRILL. WHEN THE SURGEON REMOVED THE DRILL BIT FROM THE SLEEVE, THE PATIENT BONE SCRAPED A LITTLE EXTRA. AFTER THAT THE PROCEDURE CONTINUED WITHOUT PROBLEM.

  Patient problems: No Code Available

  MAUDE report 8799480 ↗
• MalfunctionJun 17, 2019Degraded; Material Deformation; Degraded; Failure to Advance; Material Deformation; Noise, Audible

  IT WAS REPORTED THAT WHEN THE DRILLING WAS DONE WITH DRILL BIT AND DRILL SLEEVE, THE METALLIC SOUNDED AND THE DRILL DID NOT ADVANCE FURTHER. THEREFORE, THE DRILL WAS CHANGED THE NEW ONE BUT THE SAME EVENT WAS OCCURRED. THEREFORE, THE SLEEVE WAS CHANGED AND THE OPERATION WAS CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8705175 ↗
• MalfunctionJun 17, 2019Degraded; Material Deformation; Degraded; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT WHEN THE DRILLING WAS DONE WITH DRILL BIT AND DRILL SLEEVE, THE METALLIC SOUNDED AND THE DRILL DID NOT ADVANCE FURTHER. THEREFORE, THE DRILL WAS CHANGED THE NEW ONE BUT THE SAME EVENT WAS OCCURRED. THEREFORE, THE SLEEVE WAS CHANGED AND THE OPERATION WAS CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705089 ↗