THE GAP NAIL ENDO-EXO MEDULLARY SYSTEM

Additional Manufacturer Narrative

THIS DEVICE IS THE SECOND GENERATION OF THE GAP TARGETING DEVICE. ONLY ONE LOT WAS MANUFACTURED, LOT G214-01. DURING INCOMING INSPECTION, EACH DEVICE UNDERGOES A VERIFICATION PROCESS TO CONFIRM ALIGNMENT OF THE LAG REAMER WITH THE LAG HOLE OF THE NAIL. THIS IS PERFORMED BY INSERTING THE LAG REAMER INTO THE SLEEVE AND VERIFYING THAT IT PASSES THROUGH THE LAG HOLE WITHOUT CONTACTING THE NAIL. A REVIEW OF THE PRODUCTION RECORD FOR PURCHASE ORDER 9915 REVEALED NO ISSUES DURING THIS OR ANY OTHER INSPECTION. ADDITIONALLY, OVER 10 TRAYS WERE ASSEMBLED USING THIS LOT OF THE TARGETING DEVICE, AND ALL HAVE BEEN USED IN THE SURGICAL FIELD WITHOUT ANY REPORTED ISSUES. THIS SUPPORTS THE CONCLUSION THAT THE REPORTED MISALIGNMENT IS NOT DUE TO A MALFUNCTION OR MANUFACTURING DEFECT. THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. HOWEVER, ACCORDING TO THE HOSPITAL REPRESENTATIVE, THE TARGETING DEVICE SUCCESSFULLY PASSED THE DROP TEST (GRAVITY TEST) PRIOR TO SURGERY. SINCE THE DEVICE PROCEEDED TO SURGICAL USE, IT IS REASONABLE TO CONCLUDE THAT IT PASSED INITIAL FUNCTIONALITY CHECKS. GIVEN THIS CONTEXT AND THE DEVICE'S ASSEMBLY PROCEDURE, IT IS LIKELY THAT THE ISSUE RESULTED FROM IMPROPER ASSEMBLY OF THE TARGETING DEVICE ONTO THE NAIL DRIVER. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS ON APRIL 7, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI ((B)(4)). CAPA INITIATED TO ADDRESS THE ISSUE.

Description of Event or Problem

THE HOSPITAL REPRESENTATIVE REPORTED THAT THE GAP TARGETING DEVICE WAS MISALIGNED AT THE PROXIMAL HOLE.