DEVICE RECEIVED (B)(4) 2013. EVALUATION SUMMARY: PRODUCT ANALYSIS FOUND THAT THE CONDITION OF THE RETURNED DEVICE SHOWED CUSTOMER USE. FROM VISUAL EVALUATION, THE SHAFT AT THE TIP WAS FOUND BROKEN APPROXIMATELY 11MM FROM THE DISTAL TIP. UNDER MAGNIFICATION, THE BROKEN SHAFT EDGES WERE FOUND JAGGED. THE OUTER DIAMETER OF THE SHAFT WAS FOUND APPROXIMATELY 2.70MM WHICH IS MEETS THE REQUIRED SPECIFICATION OF 2.70MM +/- 0.50 AS PER ASSEMBLY DRAWING. THE TIP (PUNCH) OUTER DIAMETER MEASURED 3.49MM WHICH ALSO MEETS THE SPECIFICATION OF 3.50MM +/- 0.50MM. THE OVERALL LENGTH COULD NOT BE MEASURED DUE TO THE BROKEN SHAFT COMPONENT. THE DEVICE COULD NOT BE FUNCTIONED UPON ACTIVATION OF HANDLE DUE TO BROKEN SHAFT ASSEMBLY. THE BREAKAGE OF THE SHAFT APPEARS TO BE RELATED WITH EXCESSIVE CUSTOMER HANDLING / USE OF THE DEVICE DURING PROCEDURE. METHOD: MICROSCOPIC INSPECTION. (B)(4).
D
Patient 1
IT WAS REPORTED THAT THERE IS A PIECE THAT IS EITHER BROKEN OR MISSING FROM THE DEVICE. NO REPORTED PATIENT IMPACT.
N
Patient 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4): EVALUATION SUMMARY NOT AVAILABLE, DEVICE HAS NOT BEEN RETURNED OR EVALUATED AT THIS TIME. METHOD: ACTUAL DEVICE NOT EVALUATED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.