AXSOS 705031Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327083316), received between Jun 12, 2018 and Sep 16, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "WHILE DRILLING TO PLACE THE SCREWS, THE DRILL BIT BROKE, LEAVING THE TIP INSIDE THE PATIENT'S BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 23068242 ↗
• MalfunctionMay 28, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT WHILE USING THE AXSOS 3 TIBIAL PLATE ANCILLARY DURING OSTEOSYNTHESIS OF LEFT TIBIAL PLATEAU, THE DRILL BIT BROKE AND WAS LEFT IN THE PATIENT'S TIBIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 11902400 ↗
• MalfunctionSep 8, 2020Break; Break

  THE DRILL WAS REPORTED TO BE BROKEN.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10505083 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  AS REPORTED: "DURING AN INTERVENTION FOR A COMPLEX FRACTURE OF PROXIMAL HUMERUS: TWO DRILL BITS D.2.5 BROKEN DURING THE PERFORATION OF THE HUMERAL SHAFT, THROUGH A HOLE IN THE PLATE. BROKEN DISTAL PART RECOVERED. A DRILL BIT D.3,1, BROKEN DURING THE PERFORATION OF THE HUMERAL HEAD, THROUGH A HOLE IN THE PLATE. BROKEN DISTAL PART RECOVERED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788689 ↗
• MalfunctionDec 11, 2019Fracture; Fracture

  CUSTOMER REPORTED THAT: "BREAK AXSOS STRANDS, 2 YESTERDAY ON THE SAME PATIENT. REF (B)(4) AND (B)(4). THIS IS THE FOURTH TIME IT'S HAPPENED TO ME. THE WICK THEN REMAINS IN THE PATIENT'S BONE."

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9455282 ↗
• MalfunctionDec 27, 2018Break

  THE SCREW AND THE DRILL INTERFERED DURING PROCEDURE. IF CONTINUING THE PROCEDURE, WE WORRIED THAT THE DRILL COULD BREAK. HOWEVER THE SURGEON CONTINUED DRILLING, SO THE TIP OF THE DRILL WAS BROKEN. THE BROKEN TIPS REMAIN IN THE MARROW. ATTEMPTED TO TREAT TO REMOVE IT THAT 1 MM K WIRE BE HOOKED AND PULLED OUT OR SUCKED, BUT COULD NOT REMOVE IT. AS A RESULT, IT REMAINED IN THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8200453 ↗
• MalfunctionNov 16, 2018Inadequacy of Device Shape and/or Size

  THE SURGEON REPORTED THAT HE RECENTLY PERFORMED A CONTOURED ANTEROLATERAL DISTAL TIBIAL PLATE TO A PILON FRACTURE AND THAT MEASURING DIRECTLY AFTER DRILL, THE SCREWS IN THE DISTAL PART OF THE TIBIA WERE IN EXCESS OF A CENTIMETRE TOO LONG. THESE ALL HAD TO BE REMOVED AND REPLACED AFTER USING THE DIRECT MEASURING GUIDE. THE CUSTOMER FURTHER REPORTED THAT THERE ARE TWO SETS OF SCREW IN GUIDES AND DRILLS WHICH ARE APPROXIMATELY 15 MILLIMETRES DIFFERENT IN LENGTH AND BOTH MARKED WITH ORANGE BANDS. THE CUSTOMER IS CONCERNED THAT WITH TWO DIFFERENT DRILLS AND DRILL GUIDES IT IS POSSIBLE FOR THEM TO BE MIXED UP AND IN THIS INSTANCE HAS WASTED A NUMBER OF SCREWS, IN ADDITION TO RISKING NEUROVASCULAR STRUCTURES BY THE IMPLANTATION OF SCREWS THAT ARE TOO LONG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081163 ↗
• MalfunctionJun 12, 2018Break

  DURING AXSOS SURGERY, THE DRILL BIT BROKE INSIDE THE PATIENT'S BONE WHEN DRILLING OF A DISTAL 9TH HOLE OF A PLATE. THE BROKEN DRILL IS PLANNED TO BE REMOVED WITH THE IMPLANT REMOVAL SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7593474 ↗