UNIVER TOFFLEMIRE TYPE RE

Additional Manufacturer Narrative

TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

Description of Event or Problem

CUSTOMER INITIALLY REPORTS DOCTOR WAS CUT, ITEM DOESN'T WORK WELL. ON (B)(6) 2016 DOCTOR REPORTS SHE WAS CUT THROUGH HER GLOVE BY MATRIX BAND WHEN SHE TRIED TO APPLY IT WITH THE DEVICE. NEEDED TO APPLY A LOT OF PRESSURE. NO HARM DONE.

Additional Manufacturer Narrative

ON 9/1/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: THERE WERE (B)(4) TOFFLEMIRE RETAINERS RETURNED WITH NO UNUSUAL MARKINGS. UPON FURTHER INVESTIGATION IT IS FOUND THAT SOME DO HAVE SHARP EDGES ON THEM. THE COMPLAINT REPORT IS CONFIRMED. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: (B)(4) ISSUED (B)(6) 2010 FUNCTIONAL ISSUES DURING USE HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE HAS BEEN DETERMINED TO BE A WORKMANSHIP OR MATERIAL DEFICIENCY.