HEMI GREAT TOE IMPLANT IMPACTOR

Additional Manufacturer Narrative

ONE (1) HEMI INSTRUMENT KIT WAS RETURNED FOR EVALUATION, AND NO ISSUES WERE IDENTIFIED WITH THE RE-USABLE HEMI PUNCH. THE HEMI MEDIUM IMPLANT WAS NOT RETURNED FOR EVALUATION, AS IT WAS IMPLANTED DURING THE REPORTED EVENT. NO NCRS OR CAPAS WERE IDENTIFIED FOR THE HEMI INSTRUMENTS OR IMPLANTS IN THE TWO YEAR REVIEW. THIS IS THE FIRST REPORTED COMPLAINT FOR THE HEMI INSTRUMENTS AND IMPLANTS IDENTIFIED IN THE REVIEW. THE REPORTED COMPLAINT STATES THAT THE IMPLANT WAS SIGNIFICANTLY LARGER THAN THE PUNCH INSTRUMENT; HOWEVER, A DRAWING REVIEW IDENTIFIED THAT BOTH THE IMPLANT AND PUNCH ARE MACHINED TO THE SAME ANGLE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED DURING A HEMIARTHROPLASTY PROCEDURE, THE SURGEON STRUGGLED TO GET THE OSTEOMED HEMI GREAT TOE IMPLANT IN. THE SURGEON NOTED THAT THE PUNCH INSTRUMENT WAS SIGNIFICANTLY SMALLER THAN THE IMPLANT, AND THE SURGEON HAD TO SOFTEN THE PUNCHED AREA WITH A K-WIRE AND THEN A DRILL TO GET THE IMPLANT TO FIT IN. IT WAS REPORTED THIS ISSUE PROLONGED THE PROCEDURE BY 20-30 MINUTES, AND IT WAS DIFFICULT TO TELL IF THE IMPLANT WAS TIGHT OR LOOSE WHEN THE SURGEON FINALLY GOT THE IMPLANT SEATED. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2023-00001 FOR THE HEMI IMPLANT INVOLVED IN THIS EVENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS CURRENTLY PENDING, AND A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE HEMI IMPLANT WAS REPORTEDLY IMPLANTED; HOWEVER, IT WAS STATED THE INSTRUMENTATION IS AVAILABLE FOR RETURN.