INBONE DRILL TALAR PEG 4MM

Description of Event or Problem

AS REPORTED: "THIS CASE WAS MISSING THE TALAR PEG DRILL (IB200020) THIS CAUSED SOME ISSUES AS WE NEEDED TO SOURCE ANOTHER 4MM DRILL THAT WE COULD USE TO DRILL THE PEG HOLES. THE DRILL WE USED CAME FROM ANOTHER SET AND DIDN¿T QUITE FIT CAUSING HEAT BUILD UP ON INSPECTION AFTER THE CASE I NOTICED HEAT STRESS MARKS ON THE ADAPTIS TALAR TRIAL, AND THE DRILL BIT HAD BEEN RENDERED BLUNT. THERE WAS NO METAL DEBRIS LEFT IN THE PATIENT. THIS ISSUE CAUSED A SMALL DELAY BUT NEEDED EXTRA IMPACTION OF THE TALUS COMPONENT AS THE DRILL PROBABLY DIDN¿T DO AS GOOD A JOB AS THE REAL DEVICE. THIS PATIENT HAD A 3 TIBIA AND A 3 TALUS. IF WE HAD OPENED THE PREVIOUS SET, WE WOULD HAVE HAD SOME ISSUES WITH THE MISSING POLY IT WAS MORE LUCK THAN JUDGEMENT. I NORMALLY GET A NO STOCK FOR THESE ITEMS BUT ON THIS OCCASION, I HAD NO EMAIL WARNING OF THE STATE OF THE SETS. THE SETS ARE DUE TO BE PICKED UP TODAY CAN THEY BE QUARANTINED AND RECTIFIED BEFORE REDEPLOYMENT."

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.