MICROAIRE ENDOTINE

Additional Manufacturer Narrative

A REVIEW OF THE DESIGN HISTORY RECORD (DHR) ASSOCIATED WITH CFD-22202 LOT#: 365617 DID NOT IDENTIFY ANY ANOMALIES WITHIN THE MANUFACTURING PROCESS WHICH WOULD HAVE CAUSED/CONTRIBUTED TO THIS TYPE OF FAILURE. THIS IS THE FIRST KNOWN COMPLAINT THAT MICROAIRE SURGICAL INSTRUMENTS, LLC HAS RECEIVED FOR THIS PRODUCT # AND LOT #. MICROAIRE RECEIVED THE COMPLAINT PRODUCTS (2 DEVICES) ON (B)(6) 2022 FOR EVALUATION. VISUAL EVALUATION IDENTIFIED THAT THE COMPRESSION FLANGES WERE SHEARED OFF OF THE POST OF EACH DEVICE. THE COMPRESSION FLANGES ON THE DEVICE ASSIST WITH INTERLOCKING THE DEVICE WITHIN THE SURGICAL SITE. WITHIN THE COMPLAINT INCIDENT REPORT (CIR) THE CUSTOMER STATES THAT THE "THREE HOLES WERE DRILLED ON EACH SIDE AND THE DEVICE WOULD NOT STAY SEATED UNTIL A NEW ENDOTINE WAS USED AND THIS CAUSED A 1 HOUR DELAY IN SURGERY." ON LINE 10 WITHIN THE INSTRUCTION FOR USE (IFU) FOR THE ENDOTINE FOREHEAD DEVICE IT STATES THAT "THE DEVICE CANNOT BE REMOVED FROM THE HOLE AND REUSED." BASED ON THE CUSTOMER'S COMPLAINT, DHR, CIR AND PRODUCT EVALUATION THIS FAILURE IS LIKELY ATTRIBUTED TO AN INITIAL OFF-AXIS INSERTION AND THEN FURTHER DAMAGE WAS CAUSED TO THE IMPLANTS DUE TO THE CUSTOMERS MULTIPLE ATTEMPED INSERTIONS.

Description of Event or Problem

THE CUSTOMER STATES THAT THEY DRILLED 3 HOLES ON EACH SIDE OF THE PATIENT AND THE ENDOTINE IMPLANTS WOULD NOT SEAT. USED BACK-UP DEVICES AND THEY WORKED PERFECTLY.