APEX 5038-2-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327091748), received between Sep 1, 2015 and Mar 20, 2024 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE SALES REP THAT ONE OF THE NAVIGATION PIN WAS BROKEN AND LEFT INSIDE PATIENT TIBIA BONE WHEN SURGERY FINISHING AND SURGEON WAS DRILLING THE PIN OUT. SURGEON DECIDED TO LEAVE IT INSIDE THE PATIENT BONE. HOSPITAL RAISED SERIOUS INCIDENCE REPORT BECAUSE IT WAS CONSIDERED AS "SHARP". BASED ON THE INFORMATION PROVIDED BY THE SURGEON/HOSPITAL, THE BROKEN PIN WAS NOT REMOVED FROM THE PATIENT'S BONE. PATIENT WAS DISCHARGED TO-DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18946712 ↗
• MalfunctionDec 13, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DOING AN EX-FIX CASE WITH A SURGEON, ONE OF THE STRYKER APEX PINS FROM THE HOFFMANN II COMPACT SET COULD NOT BE REMOVED FROM PATIENT. COULD HAVE BEEN SURGEON ERROR - OR PRODUCT ERROR, BUT WANTED TO REPORT NONETHELESS. APEX PIN WOULD NOT DISLODGE FROM PATIENT'S CALCANEOUS, ULTIMATELY ENDED UP SNAPPING TRYING TO REMOVE IT. BROKEN APEX PIN REMAINED INSIDE PATIENT." IT WAS ADDITIONALLY REPORTED THAT THERE WAS A SURGICAL DELAY OF UNKNOWN LENGTH.

  Patient problems: Foreign Body In Patient

  MAUDE report 15968436 ↗
• MalfunctionOct 3, 2018Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT THE TIP OF THE SELF-DRILLING PIN BROKE OFF IN PATIENT'S RIGHT TIBIA DURING A NAVIGATED KNEE CASE. SURGEON ELECTED TO LEAVE THE TIP IN THE PATIENT'S TIBIA WITH NO SURGICAL DELAY. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR THE SURGEON.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7929892 ↗
• InjuryMay 10, 2018Break

  NAVI PIN TIP BROKEN WHILE DRILLING IN DISTAL OF TIBIA TUBERCLE. SURGICAL DELAY DISTAL OF TIBIA TUBERCLE BONE LOSS, BECAUSE SURGEON TRYING TO DIG OUT THE BROKEN PIN TIP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504780 ↗
• InjuryMay 10, 2018Break

  NAVI PIN TIP BROKEN WHILE DRILLING IN DISTAL OF TIBIA TUBERCLE. SURGICAL DELAY DISTAL OF TIBIA TUBERCLE BONE LOSS, BECAUSE SURGEON TRYING TO DIG OUT THE BROKEN PIN TIP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504667 ↗
• MalfunctionSep 18, 2017Material Fragmentation

  IT WAS REPORTED THAT DURING A NAVIGATED PRIMARY TKA ON PATIENT'S RIGHT KNEE, 2 APEX PINS BROKE OFF AT TIME OF INSERTION. THE SURGEON TOOK X-RAYS AND DETERMINED THAT IT WOULD CAUSE THE PATIENT MORE HARM TO REMOVE THE BROKEN PIECES THAN LEAVING THEM IN WOULD BE. REP REPORTED THAT THERE WAS NO SURGICAL DELAY AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REP ALSO REPORTED THAT NO FURTHER MEDICAL REPORTS, PATIENT DATA, OR X-RAYS ARE AVAILABLE DUE TO SURGEON POLICY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6874187 ↗
• MalfunctionSep 18, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A NAVIGATED PRIMARY TKA ON PATIENT'S RIGHT KNEE, 2 APEX PINS BROKE OFF AT TIME OF INSERTION. THE SURGEON TOOK X-RAYS AND DETERMINED THAT IT WOULD CAUSE THE PATIENT MORE HARM TO REMOVE THE BROKEN PIECES THAN LEAVING THEM IN WOULD BE. REP REPORTED THAT THERE WAS NO SURGICAL DELAY AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REP ALSO REPORTED THAT NO FURTHER MEDICAL REPORTS, PATIENT DATA, OR X-RAYS ARE AVAILABLE DUE TO SURGEON POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6874124 ↗
• MalfunctionDec 5, 2016Break; Detachment Of Device Component

  DURING SURGERY, TIP OF THE APEX PIN BROKE OFF IN THE PATIENT'S BONE. NO DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6146246 ↗
• MalfunctionAug 11, 2016Break; Detachment Of Device Component

  TIP OF PIN BROKE OFF AND WAS RETAINED IN PATIENTS RIGHT TIBIA WHEN INSERTING PIN TO BE USED FOR NAVIGATION TRACKER FOR RIGHT TOTAL KNEE. NO ADVERSE PATIENT EVENTS AND NO PRODUCT TO BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5869957 ↗
• MalfunctionSep 21, 2015Break; Detachment Of Device Component

  IT WAS REPORTED THAT SURGEON WAS PUTTING IN AN APEX PIN AND THE TIP OF THE PIN BROKE OFF IN THE PATIENTS' FAR CORTESIE AND WAS UN RETRIEVABLE. SURGEON USED A NEW PIN AND COMPLETED THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 5091092 ↗
• MalfunctionSep 1, 2015Break; Detachment Of Device Component

  APEX PIN TIP BROKE OFF IN NEAR CORTICES OF PATIENTS LEFT TIBIA. SURGEON EXTRACTED THE TIP WITH A QUICK OUT. HE USED ANOTHER APEX PIN TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5047133 ↗