TUNNELER 600MM RIGID

Additional Manufacturer Narrative

BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A VISIBLE DAMAGE OF THE TUNNELLER HANDLE. THE CAUSE OF THE DAMAGE IS NOT KNOWN TO US AT THE TIME OF THE EXAMINATION BECAUSE OF LIMITED INFORMATION CONCERNING THE CIRCUMSTANCES WHY A DAMAGE LIKE THIS COULD OCCUR. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE PRODUCT MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG.

Description of Event or Problem

IT WAS REPORTED THAT A TUNNELLER (#FX003SU) WAS USED FOR AN IMPLANTATION. ACCORDING TO THE COMPLAINANT, THE HANDLE OF THE TUNNELLER WAS CRACKED DURING USE. NO PATIENT COMPLICATIONS OR DELAYS WERE REPORTED AS A RESULT OF THE DAMAGE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.