PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION REVEALED THAT A PRECICE MODEL P8.5-80D245 WAS REPORTED TO HAVE BENT IN THE ACTUATOR REGION OF THE NAIL. NO PRODUCT WAS RETURNED, BUT THE PROVIDED X-RAY DOES CONFIRM THAT THE NAIL WAS BENT OUTSIDE OF ITS SPECIFICATIONS. NO LOT NUMBER WAS PROVIDED SO THE DEVICE HISTORY RECORD CANNOT BE REVIEWED FOR THE LOT'S QUALITY INSPECTIONS AND SPECIFICATIONS. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRACKING AND TRENDING PURPOSES. TRENDS WILL CONTINUE TO BE MONITORED. WITHOUT THE DEVICE, A REPORTED FAILURE OF A DAMAGED IMPLANT CANNOT BE CONFIRMED. HOWEVER, WITH THE PROVIDED PATIENT X-RAY, THE ALTERNATE OBSERVATION OF A BENT NAIL CAN BE CONFIRMED. THE PATIENT WAS REPORTEDLY NON-WEIGHT BEARING, SO A PROBABLE CAUSE COULD BE MUSCLE CONTRACTION FORCES IN THE VASTUS MEDIALIS PULLING THE DISTAL BONE SEGMENT PROXIMALLY, CAUSING A VARUS DEFORMITY. RATE IS WITHIN THE PREDICTED RATED, NO NEW HARM DETERMINED. THE ASSOCIATED RISK DOCUMENT WAS REVIEWED, AND THE FAILURE MODE, EFFECTS, AND HARMS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AND MITIGATED. 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 BY THE SURGEON THAT THE PRECICE NAIL IS VERY BENT AND REQUIRES REVISION SURGERY TO REPLACE NAIL. THE NAIL REMAINS IN SITU WITH PLAN FOR REMOVAL.

Additional Manufacturer Narrative

THE DEVICE REMAINS IN SITU BUT MAY BE REMOVED IN A FUTURE REVISION. 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 BY THE SURGEON THAT THE PRECICE NAIL IS VERY BENT AND REQUIRES REVISION SURGERY TO REPLACE NAIL. THE NAIL REMAINS IN SITU.