SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

Additional Manufacturer Narrative

THE HOSPITAL REPRESENTATIVE REPORTED THAT A PEG IMPLANT BROKE INSIDE THE PATIENT, PREVENTING THE SURGEON FROM REMOVING THEM. IT IS NOT YET CONFIRMED WHETHER A MALFUNCTION OCCURRED. THE HOSPITAL REPRESENTATIVE HAS BEEN CONTACTED FOR CLARIFICATION, BUT NO INFORMATION HAS BEEN RECEIVED SO FAR. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2025-00006 ON AUGUST 29, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

Description of Event or Problem

THE HOSPITAL REPRESENTATIVE REPORTED THAT A PEG IMPLANT BROKE INSIDE THE PATIENT, PREVENTING THE SURGEON FROM REMOVING THEM.

Additional Manufacturer Narrative

ON (B)(6) 2025, DURING A SLIM REMOVAL SURGERY AT (B)(6), A PEG SCREW BROKE INSIDE THE PATIENT. THE SLIM NAIL WAS FULLY REMOVED AND SHOWED NO SIGNS OF DEFORMATION OR BREAKAGE, BUT THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PEG FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND NO REVISION SURGERY IS PLANNED. THE ISSUE CAUSED A DELAY OF 16-29 MINUTES. PATIENT INFORMATION SUCH AS WEIGHT AND AGE IS NOT AVAILABLE, AND THE SIZE AND LOT NUMBER OF THE BROKEN PEG CANNOT BE DETERMINED. INVESTIGATION FINDINGS: · THE SURGERY WAS TRIGGERED BY THE PEG BREAKAGE; THE BREAK DID NOT OCCUR DURING THE REMOVAL PROCEDURE. · UPON REMOVAL, THE SLIM NAIL SHOWED NO SIGNS OF DEFORMATION OR BREAKAGE. · ADDITIONAL INFORMATION FROM THE REPORTING CONTACT DID NOT PROVIDE INSIGHT INTO A DEFINITIVE ROOT CAUSE. · NO SIMILAR PRIOR OCCURRENCES HAVE BEEN REPORTED. ROOT CAUSE CONSIDERATIONS: KEY OBSERVATIONS SUPPORTING POTENTIAL CAUSES: · THE SLIM NAIL REMAINED INTACT, SHOWING NO DEFORMATION, SO THE ISSUE SEEMS LOCALIZED TO THE PEG SCREW. · THIS IS AN ISOLATED EVENT; NO PRIOR REPORTS OF PEG BREAKAGE SUGGEST EITHER A RARE MECHANICAL/MATERIAL FAILURE OR PATIENT-SPECIFIC FACTORS. IN SUMMARY, THE MOST LIKELY CAUSES ARE AN ISOLATED MATERIAL DEFECT OR MECHANICAL OVERLOAD DUE TO EARLY WEIGHT-BEARING OR ANATOMICAL FACTORS, WITH PEG SIZING/FIT AS A POSSIBLE CONTRIBUTING FACTOR. NO DEFINITIVE ROOT CAUSE CAN BE CONFIRMED. CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME DUE TO THE ISOLATED NATURE OF THE EVENT AND THE ABSENCE OF A CONFIRMED DEVICE MALFUNCTION. COMPLAINT TRENDING WILL CONTINUE TO MONITOR, AND A FORMAL INVESTIGATION WILL BE RE-OPENED IF ADDITIONAL OCCURRENCES ARE REPORTED.