AXSOS 705015Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327091649), received between May 2, 2018 and Sep 21, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fracture

  The primary surgery was performed on (b)(6) 2024.The tip of the screwdriver broke while removing a locking screw. The plate and screw head were broken up using a carbide drill, and the remaining screw was extracted using the hospital¿s broken-screw extractor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840847 ↗
• MalfunctionMar 17, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "TORX15 SCREWDRIVER OR SCREWDRIVER BIT TWISTED OFF OR BROKEN OFF WHEN INSERTING THE SCREWS, A DIFFERENT SCREWDRIVER WAS THEN USED. BOTH THE BIT AND THE SCREWDRIVER ARE 3 YEARS OLD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621802 ↗
• MalfunctionNov 28, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN SCREWDRIVER."

  Patient problems: Insufficient Information

  MAUDE report 20805633 ↗
• MalfunctionOct 15, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AN ISSUE WAS OBSERVED WITH A PANGEA T15 SHORT SCREWDRIVER SHAFT WHILE USING A TORQUE LIMITER TO PLACE LOCKING SCREWS IN A PROXIMAL HUMERUS PLATE. AFTER SUCCESSFULLY PLACING 3-5 SCREWS, THE TIP OF THE SCREWDRIVER SHAFT TWISTED, LEAVING SMALL METAL FRAGMENTS IN THE SCREW HEAD. DESPITE A BRIEF 3-5 MINUTE SURGICAL DELAY TO ATTEMPT REMOVAL OF THE FRAGMENTS USING A CURETTE AND BONE HOOK, SOME DEBRIS REMAINED IN THE PATIENT. THE SURGEON EXPRESSED CONCERN THAT A PIECE OF THE DRIVER HEAD MAY HAVE COLD-WELDED TO THE SCREW, POTENTIALLY COMPLICATING FUTURE REMOVAL OF THE PLATE. LONG-TERM COMPLICATIONS MAY ARISE IF THE SCREW HEAD IS DEFORMED, WHICH WOULD REQUIRE MORE SPECIALIZED EQUIPMENT, SUCH AS A CARBIDE DRILL BIT OR MIDAS REX, FOR REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20456223 ↗
• InjuryJul 24, 2024Break; Fracture; Break; Fracture

  A PLATE AND A SCREW WERE COMPLETELY LOCKED AND THE SCREWDRIVER WAS BROKEN DURING REMOVAL PROCEDURE. THUS, THE SURGEON REMOVED THE SCREW HEAD USING A CARBIDE DRILL, AND THE TIP OF THE SCREW WAS REMOVED AFTER THE PLATE WAS REMOVED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820419 ↗
• MalfunctionMar 26, 2021Fracture; Fracture

  AS REPORTED: "SCREW BREAKAGE IN AXSOS 3 DISTAL MEDIAL PLATE DESCRIBED BY CUSTOMER AS COLD WELDING. PROXIMAL LOCKING SCREW MEASURED TOO LONG, WHEN GOING TO CHANGE THE SCREW OUT THE SCREW HEAD BROKE. THE LOCKING TOWER WAS USED CORRECTLY, THE TORQUE WRENCH WAS USED TO TIGHTEN THE SCREW INITIALLY. INITIAL REMOVAL WAS ATTEMPTED ON HAND SCREWDRIVER. A BROKEN SCREW REMOVAL SET WAS USED TO REMOVE THE BROKEN SCREW FROM THE LATERAL SIDE, TO DO THIS A BURR WAS USED TO REMOVE A PORTION OF A FIBULA PLATE WHICH HAD BEEN PLACED IN THE SAME OPERATION. 2 SCREW DRIVER SHAFTS WERE BROKEN IN THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577487 ↗
• MalfunctionMar 26, 2021Fracture; Fracture

  AS REPORTED: "SCREW BREAKAGE IN AXSOS 3 DISTAL MEDIAL PLATE DESCRIBED BY CUSTOMER AS COLD WELDING. PROXIMAL LOCKING SCREW MEASURED TOO LONG, WHEN GOING TO CHANGE THE SCREW OUT THE SCREW HEAD BROKE. THE LOCKING TOWER WAS USED CORRECTLY, THE TORQUE WRENCH WAS USED TO TIGHTEN THE SCREW INITIALLY. INITIAL REMOVAL WAS ATTEMPTED ON HAND SCREWDRIVER. A BROKEN SCREW REMOVAL SET WAS USED TO REMOVE THE BROKEN SCREW FROM THE LATERAL SIDE, TO DO THIS A BURR WAS USED TO REMOVE A PORTION OF A FIBULA PLATE WHICH HAD BEEN PLACED IN THE SAME OPERATION. 2 SCREW DRIVER SHAFTS WERE BROKEN IN THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577436 ↗
• MalfunctionMay 2, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT DURING AN AXSOS PROXIMAL HUMERUS CASE, THE SCREWDRIVER BIT WHICH IS ATTACHED TO THE TORQUE LIMITING ADAPTOR WAS USED TO INSERT THE SCREW BY HAND. PRIOR TO ACHIEVING 2.5NM TORQUE, THE TIP OF THE SCREWDRIVER BROKE OFF. IT WAS REPORTED THAT THE BROKEN TIP REMAINED INSIDE THE SCREW-HEAD. IT WAS REPORTED THAT THE SCREW WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7481055 ↗