SYMMETRY VERITY

Additional Manufacturer Narrative

IN THE PREVIOUS MDR SUBMISSION 3007208013-2023-00006-02 SECTION G4 WAS MARKED AS COMBINATION PRODUCT. THIS IS INCORRECT AND SHOULD HAVE BEEN SELECTED.

Additional Manufacturer Narrative

THE DEVICES WERE RECEIVED AND PROCESSED ON 2/27/2023. THE DEVICES WERE THEN SENT TO THE MANUFACTURING LOCATION FOR ADDITIONAL REVIEW AND EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE RECEIVED THE EVALUATION REPORT OF THE RETURNED DEVICES.

Additional Manufacturer Narrative

THE DEVICE IS BEING RETURNED FOR EVALUATION, BUT HAS NOT BEEN RECEIVED YET. THIS IS THE FIRST COMPLAINT RECORDED FOR THIS PRODUCT CODE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE COMPLETE OUR EVALUATION.

Description of Event or Problem

DURING AN ANTERIOR CERVICAL DISECTOMY THE BALL TIP OF THE NERVE HOOK BROKE OFF. THEY NOTICED THE DAMAGED NERVE HOOK AFTER THE PROCEDURE AND SENT THE PATIENT IT IMAGING. THE IMAGING CONFIRMED THAT THAT THE BALL TIP REMAINED THE PATIENT. THE DOCTOR DETERMINED THAT AN ADDITIONAL SURGERY WAS NOT NECESSARY TO REMOVE THE TIP.

Additional Manufacturer Narrative

THE RETURNED DEVICES WERE SENT TO THE MANUFACTURING LOCATION FOR FURTHER EVALUATION. MATERIAL: TO MANUFACTURE THIS INSTRUMENT WAS USED TI-6AL-4V, TITANIUM GRADE 5 ALLOY (UNSR56400). THE CHEMICAL COMPOSITION OF WHICH AND QUALITY CERTIFICATE ARE ATTACHED. WORKLOAD TEST: FOR TESTING, INSTRUMENTS FROM THE SAME LOTS (2204 AND 2205) WERE USED. THEY WERE SUBJECTED TO THE INTERNAL TESTING PROCEDURE ON A TENSILE TESTING MACHINE (THE INSTRUMENT HANDLE WAS FIXED MOTIONLESS, AND A FORCE WAS APPLIED TO THE WORKING PART ALONG THE INSTRUMENT AXIS UNTIL REACHING THE BREAKING POINT. EACH TIME THE INSTRUMENT'S NECK RUPTURE OCCURRED WHEN THE WORKLOAD FORCE WAS ABOVE 245N (55 POUND-FORCE). CONCLUSION: THIS IS A MICROSURGICAL INSTRUMENT, DESIGNED TO WORK WITH MICROVASCULAR AND NEURAL TISSUE, WHICH DOES NOT IMPLY THE APPLICATION OF WORKLOAD FORCES EXCEEDING 105N (23.6 POUND-FORCE). BASED ON THE PURPOSE OF THE INSTRUMENT, THE RMA REPORT IMAGES AND THE INTERNAL WORKLOAD TESTING, IT WAS CONCLUDED THAT THE INSTRUMENT MET QUALITY STANDARDS AND WAS NOT USED FOR ITS INTENDED PURPOSE. IF INSTRUMENT WAS USED AS INTENDED, THE DAMAGE TO THE INSTRUMENT PROVES THERE WAS SOME KIND OF MECHANICAL FORCE APPLIED THAT CAUSED THE SEVERE PHYSICAL DEFORMATION PRIOR TO USE. THESE DELICATE INSTRUMENTS ARE NOT MALLEABLE. THEY ARE DESIGNED FOR HIGH PRECISION MICROSURGICAL PROCEDURES. THERE SHOULD NOT BE ANY DINGS, DENTS, OR BENDS ON THESE ITEMS. WHEN THE ITEMS LOOK AS THESE DO, THEY SHOULD NO LONGER BE USED. THIS TYPE OF INSTRUMENT DAMAGE CAN BE CAUSED BY DROPS AND/OR IMPROPER HANDLING DURING THE STERILIZATION PROCESS, CAUSING UNFORESEEN INSTRUMENT DEFORMATION WHICH COULD GET WORSE UPON USE. BASED ON THE MANUFACTURING LOCATIONS EVALUATION, IT CAN BE DETERMINED THAT THE ROOT CAUSE CAN BE ATTRIBUTED TO USER ERROR. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL INFORMATION PERTINENT TO THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.