VERITY NERVE HOOK TITANIUM HANDLE, 3.0 MM

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE BROKE IN THE AREA WHERE THE PROBE WAS BENT DURING PRODUCTION. WHEN ITEMS ARE BENT, THERE IS AN INCREASE IN THE STRESS CONCENTRATION IN THE AREA OF THE BEND. AS A RESULT, THE TIP OF THE PROCE IS SUSCEPTIBLE TO FRACTURING UNDER EXCESSIVE FORCE. THE ROOT CAUSE IS USER ERROR FOR USING EXCESSIVE FORCE ON THE INSTRUMENT. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "I HAVE A CUSTOMER (B)(6) IFS- (B)(6) THAT IS REQUESTING A QUALITY REVIEW FOR TWO INSTRUMENTS THAT THEY HAVE HAD THAT ARE REPORTED TO HAVE BROKEN DURING A PROCEDURE. NO PATIENTS WERE HARMED, BUT THE SAME CATALOG NUMBER HAS BROKEN TWICE, SO THEY WANTED US TO LOOK INTO IT."