NA 6007-003-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 37613154107408), received between Jun 25, 2018 and Sep 30, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CUSTOMER, WHEN USING THE NAVIGATION DEVICE TWO PINS WERE USED TO STAND THE TRACKER ON THE FEMUR, ONE OF WHICH PENETRATED THE CORTICAL BONE, CAUSING A SUPRACONDYLAR FRACTURE. THE CUSTOMER STATES THAT AFTER THE TOTAL KNEE ARTHROPLASTY PROCEDURE WAS COMPLETED A SUPRACONDYLAR FRACTURE OCCURRED AND THE PATIENT UNDERWENT REVISION SURGERY AND PLATE FIXATION AT A LATER DATE. PER FURTHER CLARIFICATION FROM THE SURGEON, "THE PATIENT'S BONE QUALITY IS NOT STRONG," IN THE AREA WHERE THE PINS WERE PLACED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15518905 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2021 A TOTAL KNEE PROCEDURE WAS PERFORMED AT THE USER FACILITY, ON (B)(6) 2021 THE PATIENT EXPERIENCED A SUPRA FEMORAL FRACTURE IN THE SAME AREA. THE PATIENT WAS TREATED FOR THE FRACTURE. THERE ARE NO FURTHER KNOWN ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 11757499 ↗
• InjuryNov 18, 2020Break; Fracture; Break; Fracture

  PER THE SURGEON WHOM PERFORMED THE PROCEDURE AT THE USER FACILITY THE ORTHOLOCK NAVIGATION PIN INSERTION WAS LATERALLY DISPLACED AND BECAME TRANSCORTICAL. SOMETIME AFTER THE PROCEDURE THE PATIENT'S FEMUR BROKE. PER THE SURGEON THERE IS NO ALLEGATION OF A MALFUNCTION BY THE ORTHOLOCK PIN OR ANY MEDICAL DEVICE USED DURING THE PROCEDURE. MEDICAL INTERVENTION WAS NEEDED TO TREAT THE BROKEN FEMUR. THERE ARE NO FURTHER KNOWN ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION ASSOCIATED WITH THE PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 10864133 ↗
• InjuryOct 1, 2019Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A UKA SURGERY, THE DEVICE WAS INSERTED INTO THE FEMUR, BUT IT WAS DIFFICULT TO ENTER. THE IMAGE WAS CHECKED AND THE PIN WAS BENT. WHEN THE HEALTH CARE PROFESSIONAL TRIED TO REMOVE IT, THE PIN BROKE FROM THE THREAD AT THE TIP. THE OPERATION WAS COMPLETED WITH AN ALTERNATIVE PIN. AT THE TIME OF CREATING A PEG HOLE AFTER CUTTING THE FEMUR, THE PEG HOLE WAS FURTHER DEEPENED WITH A HANSON PIN DRILL, AND THE BROKEN PART WAS EXTRACTED WITH FORCEPS. IT WAS REPORTED THAT THERE WERE NO PARTS OF THE PIN LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9139869 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE NAVIGATION PIN WAS STUCK TOO DEEP INTO THE FIBULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; OR MEDICAL INTERVENTION. IT WAS FURTHER REPORTED THAT A SYMPTOM LIKE PERONEAL PARALYSIS WAS OBSERVED AFTER THE PROCEDURE. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: Paralysis

  MAUDE report 7635706 ↗