INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

AS REPORTED BY THE REP: "IMPLANTS EXPANDED IMMEDIATELY AFTER TAKING OUT FROM THE PACKAGING SO THE IMPLANT COULD NOT BE INSERTED." THE CUSTOMER CONFIRMED THAT THE IMPLANTS WERE STORED AT 0 DEGREES CELSIUS, OR BELOW, FOR A MINIMUM OF 2 HOURS BEFORE THE PROCEDURE AND WERE ONLY REMOVED FROM COLD STORAGE AT THE TIME OF IMPLANTING, AND NOT PRIOR. THE SURGEON HAD TO SWITCH TO INSERTING A TEMPORARY GUIDEWIRE TO TREAT THE PATIENT¿S HAMMERTOE. THIS WAS DIFFERENT TO WHAT WAS PLANNED BUT WAS THE ONLY WAY TO STABILIZE THE JOINT.

Description of Event or Problem

AS REPORTED BY THE REP: "IMPLANTS EXPANDED IMMEDIATELY AFTER TAKING OUT FROM THE PACKAGING SO THE IMPLANT COULD NOT BE INSERTED." THE CUSTOMER CONFIRMED THAT THE IMPLANTS WERE STORED AT 0 DEGREES CELSIUS, OR BELOW, FOR A MINIMUM OF 2 HOURS BEFORE THE PROCEDURE AND WERE ONLY REMOVED FROM COLD STORAGE AT THE TIME OF IMPLANTING, AND NOT PRIOR. THE SURGEON HAD TO SWITCH TO INSERTING A TEMPORARY GUIDEWIRE TO TREAT THE PATIENT¿S HAMMERTOE. THIS WAS DIFFERENT TO WHAT WAS PLANNED BUT WAS THE ONLY WAY TO STABILIZE THE JOINT.

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A PHOTO SHOWING A FREEZER AND THE TEMPERATURE OF -1.3 DEGREES CELSIUS DISPLAYED ON THE THERMOMETER WAS RECEIVED FOR INSPECTION. HOWEVER, THIS DID NOT BRING ANY USEFUL INFORMATION FOR THE INVESTIGATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. ACCORDING TO THE INFORMATION PROVIDED, THE CONDITIONS OF STORAGE OF THE DEVICE WHERE RESPECTED, HOWEVER, IT IS IMPOSSIBLE TO CONFIRM THIS. FURTHERMORE, IT WAS COMMUNICATED BY THE SALES REPRESENTATIVE THAT THE IMPLANT WAS STORED IN THE FREEZER AT A TEMPERATURE OF -13 DEGREES CELSIUS, HOWEVER, -1.3 DEGREE CELSIUS SEEMS TO BE DISPLAYED ON THE PHOTO RECEIVED. IN SPITE OF THIS CONTRADICTORY INFORMATION, BOTH TEMPERATURES ARE ACCORDING TO THE INSTRUCTIONS OF STORAGE. IT MUST ALSO BE NOTED THAT NO SIMILAR COMPLAINT HAS BEEN PREVIOUSLY OPENED FOR THIS CATALOG. THE MANUFACTURING DOCUMENTS OF THIS LOT WERE REVIEWED AND THERE WAS NO INDICATION OF POSSIBLE MANUFACTURING OR MATERIAL RELATED ISSUE. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.