APEX 5038-2-110SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540435408), received between Jul 30, 2018 and Sep 25, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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 25, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "DURING A PRECISION NAVIGATION TKA CASE. THE APEX PIN SNAPPED INSIDE THE PATIENTS TIBIA DURING INSERTION AT THE START OF THE CASE. THE BROKEN END COULD NOT BE RETRIEVED AND A NEW PIN WAS OPENED AND USED. SURGICAL DELAY WHILE TRYING TO RETRIEVE THE BROKEN END."

  Patient problems: Foreign Body In Patient

  MAUDE report 23144772 ↗
• MalfunctionNov 13, 2020Fracture; Fracture

  AS REPORTED: " 3 X STERILE APEX PINS REF NUMBER, (B)(4) WERE USED IN A NAVIGATED HIGH TIBIAL OSTEOTOMY CASE, INSERTED WITH A WIRED DRIVER, UPON REMOVAL WITH THE WIRE DRIVER POST FINISHING THE CASE IT WAS NOTED THAT THE TIPS OF THE PINS HAD BROKEN OFF. NOTICED AFTER SURGERY WAS COMPLETED AND REMOVING THE PINS."

  Patient problems: Foreign Body In Patient

  MAUDE report 10840129 ↗
• MalfunctionNov 13, 2020Fracture; Fracture

  AS REPORTED: " 3 X STERILE APEX PINS REF NUMBER , (B)(4) WERE USED IN A NAVIGATED HIGH TIBIAL OSTEOTOMY CASE, INSERTED WITH A WIRED DRIVER, UPON REMOVAL WITH THE WIRE DRIVER POST FINISHING THE CASE IT WAS NOTED THAT THE TIPS OF THE PINS HAD BROKEN OFF. NOTICED AFTER SURGERY WAS COMPLETED AND REMOVING THE PINS."

  Patient problems: Foreign Body In Patient

  MAUDE report 10839995 ↗
• MalfunctionNov 13, 2020Fracture; Fracture

  AS REPORTED: " 3 X STERILE APEX PINS REF NUMBER , (B)(4) WERE USED IN A NAVIGATED HIGH TIBIAL OSTEOTOMY CASE, INSERTED WITH A WIRED DRIVER, UPON REMOVAL WITH THE WIRE DRIVER POST FINISHING THE CASE IT WAS NOTED THAT THE TIPS OF THE PINS HAD BROKEN OFF. NOTICED AFTER SURGERY WAS COMPLETED AND REMOVING THE PINS."

  Patient problems: Foreign Body In Patient

  MAUDE report 10839954 ↗
• MalfunctionAug 29, 2019Break

  APEX PINS WERE USED TO ATTACH AN ORTHOLOCK TO THE TIBIA DURING A NAVIGATED TOTAL KNEE. THE TIP OF THE APEX PIN DRILL WAS BROKEN AT THE TIME OF REMOVAL OF THE PIN FROM THE TIBIAL SHAFT AND RETAINED IN THE BONE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8946783 ↗
• MalfunctionAug 29, 2019Break

  APEX PINS WERE USED TO ATTACH AN ORTHOLOCK TO THE TIBIA DURING A NAVIGATED TOTAL KNEE. THE TIP OF THE APEX PIN DRILL WAS BROKEN AT THE TIME OF REMOVAL OF THE PIN FROM THE TIBIAL SHAFT AND RETAINED IN THE BONE. SURGICAL DELAY. THE SURGEON DECIDED TO X-RAY THE PATIENTS TIBIA TO CONFIRM THE TIP OF THE APEX PIN WAS STILL LODGED IN THE CORTEX.

  Patient problems: Foreign Body In Patient

  MAUDE report 8946675 ↗
• MalfunctionJul 30, 2018Break

  BROKEN 3 MM APEX PINS DURING REMOVAL FROM BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732920 ↗
• MalfunctionJul 30, 2018Break

  BROKEN 3MM APEX PINS DURING REMOVAL FROM BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732855 ↗