APEX 5018-5-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327091939), received between Aug 21, 2019 and Jan 5, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  AS REPORTED: "IN A CASE WHERE THE APEXPIN SHARP END SHOULD HAVE BEEN SHIPPED, THE BLUNT END WAS SHIPPED IN ERROR. FINALLY, ANOTHER COMPANY'S PRODUCT WAS USED, BUT THERE WAS A 30-MINUTE DELAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171448 ↗
• MalfunctionAug 13, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT WHEN INSERTING THE APEX PIN INTO THE TIBIAL DIAPHYSIS, THE SURGEON ATTACHED THE APEX PIN TO THE HANDPIECE AND TRIED TO INSERT IT INTO THE PATIENT'S BONE, BUT WHEN IT WAS INSERTED ABOUT 10MM, IT STOPPED PROGRESSING. THE APEX PIN BROKE AS SOON AS IT WAS CHANGED TO THE MANUAL INSERTION. SINCE THE TIP OF 10 MM REMAINED ON THE BONE, THE BROKEN TIP WAS REMOVED BY SCRAPING AROUND IT, THE BONE WAS SHAVED TO REMOVE THE PIN TIP. THE SURGERY WAS CONTINUED BY INSERTING THE APEX PIN IN ANOTHER POSITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12318870 ↗
• MalfunctionJul 29, 2021Break; Break

  THE SURGEON HAD TO CONVERT INTRAOPERATIVELY FROM A MEDLINE ANKLE FRACTURE TO A STRYKER HOFFMANN EXTERNAL FIXATOR DUE TO PATIENT HAVING BLISTERS ON THEIR FOOT. THE SALES REP WAS NOT NOTIFIED. THE SURGEON PLACED 2 5MM X150MM APEX PINS IN THE PATIENTS RIGHT TIBIA. AFTER TRYING TO ADVANCE THE PIN THROUGH THE SECOND CORTICAL BONE AND NOT BEING ABLE TO, THE SURGEON THAN TRIED TO BACK THE APEX PIN OUT SO THAT HE COULD PRE-DRILL FOR THE PIN. THE SURGEON TRIED TO TAKE THE APEX PIN OUT FIRST WITH 4400 AND SYSTEM 7 POWER AND THAN BY HAND. WHILE THEY WERE USING THE HAND CRANK THE FIRST APEX PIN BROKE OFF WITH THE TIP STUCK IN THE PATIENTS TIBIA. THEY THEN MOVED TO THE SECOND APEX PIN AND TRIED THE SAME PROCEDURE IN WHICH THE SECOND APEX PIN BROKE OFF IN THE PATIENTS TIBIA AS WELL. THEY THEN PRE-DRILLED AND PLACED TWO NEW APEX PINS AND COMPLETED THE SURGERY WITH THE TWO BROKEN PIECES REMAINING IN THE PATIENTS BONE TO BE TAKEN OUT AT A LATER TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12247219 ↗
• MalfunctionJul 29, 2021Break; Break

  THE SURGEON HAD TO CONVERT INTRAOPERATIVELY FROM A MEDLINE ANKLE FRACTURE TO A STRYKER HOFFMANN EXTERNAL FIXATOR DUE TO PATIENT HAVING BLISTERS ON THEIR FOOT. THE SALES REP WAS NOT NOTIFIED. THE SURGEON PLACED 2 5MM X150MM APEX PINS IN THE PATIENTS RIGHT TIBIA. AFTER TRYING TO ADVANCE THE PIN THROUGH THE SECOND CORTICAL BONE AND NOT BEING ABLE TO, THE SURGEON THAN TRIED TO BACK THE APEX PIN OUT SO THAT HE COULD PRE-DRILL FOR THE PIN. THE SURGEON TRIED TO TAKE THE APEX PIN OUT FIRST WITH 4400 AND SYSTEM 7 POWER AND THAN BY HAND. WHILE THEY WERE USING THE HAND CRANK THE FIRST APEX PIN BROKE OFF WITH THE TIP STUCK IN THE PATIENTS TIBIA. THEY THEN MOVED TO THE SECOND APEX PIN AND TRIED THE SAME PROCEDURE IN WHICH THE SECOND APEX PIN BROKE OFF IN THE PATIENTS TIBIA AS WELL. THEY THEN PRE-DRILLED AND PLACED TWO NEW APEX PINS AND COMPLETED THE SURGERY WITH THE TWO BROKEN PIECES REMAINING IN THE PATIENTS BONE TO BE TAKEN OUT AT A LATER TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12246509 ↗
• MalfunctionOct 11, 2019Break; Difficult to Remove

  THE PATIENTS WITH HARD BONES, PRE-DRILLED AND CREATED A BONE HOLE AND INSERTED APEX-PINNED, BUT DIFFICULT TO PENETRATE CONTRALATERALLY. WHEN THE INSERTION WAS ATTEMPTED MANUALLY, THE SELF-TAP PART AT THE TIP OF THE HALF PIN WAS BROKEN AND DIFFICULT TO REMOVE, AND THE BROKEN PART WAS LEFT IN PATIENT AND THE PROCEDURE WAS COMPLETED USING A SEPARATE HALF PIN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179753 ↗
• MalfunctionAug 21, 2019Fracture; Detachment of Device or Device Component; Fracture

  AGENT REPORTED THAT A THE TIP OF AN APEX FICHE REMAINED IN THE PATIENT'S BODY. 10 MINUTES DELAY IN THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8915010 ↗