PKG, 5MM FEMORAL THREE FLUTED REAMER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE THE INSTRUMENT BROKE DURING AN ANKLE LIGAMENT SURGERY. THE INCIDENT OCCURRED WHILE CREATING A TUNNEL IN THE ANKLE. THE FRONT OF THE REAMER BROKE INTO SEVERAL PIECES. RADIOLOGICAL IMAGING WAS DONE TO CHECK FOR THE PRESENCE OF ANY POTENTIAL DEBRIS, WHICH CONFIRMED ALL PIECES WERE REMOVED.