PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PRECICE NAIL WAS DISCOVERED AS CRACKED DURING THE EXTRACTION SURGERY, WE ARE UNCERTAIN AT THIS STAGE WHETHER THE CRACK OCCURRED BEFORE OR DURING EXTRACTION, CURRENT UNDERSTANDING IS THAT IT DID NOT AFFECT THE PATIENT'S SURGICAL OUTCOME. THIS EVENT OCCURRED IN UK.

Additional Manufacturer Narrative

THE INVESTIGATION REVEALED THAT A PRECICE ANTEGRADE FEMUR, TROCHANTER BEND, 8.5MM X 275MM NAIL WAS DISCOVERED TO HAVE A CRACK IN ITS DISTAL HOUSING TUBE DURING THE EXTRACTION PROCEDURE. IT IS UNKNOWN IF THE CRACK OCCURRED DUE TO THE EXTRACTION METHOD, OR IF THE NAIL WAS CRACKED PRIOR TO EXTRACTION. THE NAIL WAS UNABLE TO BE RETURNED TO GLOBUS MEDICAL FOR EVALUATION. HOWEVER, THE PROVIDED IMAGES SHOW THAT THE NAIL HAS A FRACTURE AT THE DISTRACTION ROD-HOUSING TUBE JUNCTION, CONFIRMING THE COMPLAINT OF A BROKEN NAIL. BECAUSE THE FRACTURE WAS DISCOVERED AFTER THE PATIENT'S TREATMENT WAS COMPLETED, IT CANNOT BE KNOWN IF THE FRACTURE WAS DUE TO WEIGHT-BEARING NON-COMPLIANCE OR BECAUSE OF THE POSSIBLE EXCESSIVE FORCE USED DURING THE EXTRACTION SURGERY. A FRACTURE AT THE DISTRACTION ROD-HOUSING TUBE JUNCTION IS USUALLY AN INDICATION OF EXCESSIVE TORSIONAL FORCES EXPERIENCED BY THE NAIL DURING THE LIFETIME THAT THE NAIL IS IMPLANTED. THE JUNCTION IS THE WEAKEST PORTION OF THE NAIL WHERE THE HOUSING TUBE WALL IS AT ITS THINNEST, MEANING THAT WHEN A PATIENT EXCEEDS WEIGHT BEARING PROTOCOLS OUTLINED IN THE PRECICE IMLL IFU, THE FRACTURE IS SEEN AT THIS LOCATION ON THE NAIL. A DEVICE HISTORY REVIEW WAS COMPLETED. A REVIEW OF THE DHR DOCUMENTS INDICATES THE DEVICE WAS MANUFACTURED BY THE SPECIFIED REQUIREMENT AT THE TIME AND MET ALL THE REQUIRED INSPECTIONS BEFORE SHIPMENT. THE ASSOCIATED RISK DOCUMENT WAS REVIEWED, AND THE FAILURE MODE, EFFECTS, AND HARMS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AND MITIGATED. NO HARM WAS REPORTED, ONLY A PRODUCT MALFUNCTION WAS DOCUMENTED. THEREFORE, THIS COMPLAINT WILL NOT BE USED FOR OCCURRENCE OF HARM CALCULATIONS. FURTHERMORE, THE COMPLAINT RATE IS WITHIN THE ESTIMATED RATE IN THE RISK DOCUMENTATION ASSOCIATED WITH THIS PRODUCT. BASED ON THIS RISK ASSESSMENT, NO NEW OR ADDITIONAL RISK EVALUATION IS NECESSARY.

Description of Event or Problem

IT WAS REPORTED THAT THE PRECICE NAIL WAS DISCOVERED AS CRACKED DURING THE EXTRACTION SURGERY, WE ARE UNCERTAIN AT THIS STAGE WHETHER THE CRACK OCCURRED BEFORE OR DURING EXTRACTION, CURRENT UNDERSTANDING IS THAT IT DID NOT AFFECT THE PATIENT'S SURGICAL OUTCOME. THIS EVENT OCCURRED IN UK.