1.5X4MM HT SD X-DR SCR EA

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: A2, B5, D10, E1, H2, H3, H4, H6 AND H11. D10 - CONCOMITANT MEDICAL PRODUCTS: ITEM #: 01-7104 ITEM NAME: 1.5 5 HOLE XLONG Y LOT #: J7698662 ITEM #: 01-7136 ITEM NAME: 1.5 2X3 HOLE RECTANGLE LOT #: 241750 ITEM #: 01-8664 ITEM NAME: PLATE RGD 1.5/0.6 4 HOLE LOT #: 722460 ITEM #: 91-6104 ITEM NAME: 1.5X4MM HT SD X-DR SCR EA LOT #: J66803168 QTY: 7 ITEM #: 01-9123 ITEM NAME: DEPTH GAGE 1.5/2.0 45MM LOT #: INT019123 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PRODUCT WAS NOT RETURNED AS IT WAS RETAINED BY THE PATIENT. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE. DURING THE PROCEDURE, TWO SELF-DRILLING SCREWS FRACTURED AFTER BEING IMPLANTED IN THE CRANIAL REGION. THE FRACTURED DEVICES WERE RETAINED. DUE TO THE EVENT, THERE WAS A SMALL DELAY IN THE PROCEDURE. PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE PATIENT HAD CANCER AND UNDERWENT A CRANIOTOMY TO REMOVE A TUMOR. THE PATIENT SUFFERED A HEMATOMA THAT WAS NOT RELATED TO THE IMPLANTED PRODUCT AND THE SURGEON STATED THIS IS THE REASON THE PATIENT EXPIRED.

Additional Manufacturer Narrative

COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM # 91-6104, LOT # J67068443: 1.5X4MM HT SD X-DR SCR EA. G2: FOREIGN SOURCE: BRAZIL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT IS REPORTED THAT DURING A CRANIAL PROCEDURE, TWO SCREWS FRACTURED DURING THE PROCEDURE AFTER IMPLANTATION. THE SCREWS REMAIN IN THE PATIENT. PATIENT WILL BE MONITORED FOR ANY PROBLEMS THAT MIGHT BE CONCERNED.