VA LOCKSCR Ø2.4 SELF-TAP L12 TAN

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN.

Additional Manufacturer Narrative

THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS. IT WAS REPORTED THAT THERE WERE VISIBLE CHIPS ON THE SCREW HEAD. THE SCREW WAS NOTED TO BE IN AN UNOPENED PACKAGE TAKEN FROM STOCK. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ONE SCREW WAS RECEIVED WITH THE TASK ASSOCIATED WITH THIS COMPLAINT. THIS SCREW IS PACKAGED IN A SYNTHES (B)(4) MARKET TYPE BAG. THE PACKAGE WAS PROPERLY SEALED WITH NO TEARS OR OPENINGS OF ANY KIND. IT IS IDENTIFIED AS PART NUMBER 04.210.112, LOT NUMBER 6818859. THE PART WAS FIRST EXAMINED UNDER 10 X MAGNIFICATIONS THROUGH THE SEALED BAG. CHIP WRAP WAS FOUND IN THE NECK AREA OF THE SCREW. THE PACKAGE WAS THEN OPENED TO FURTHER EXAMINE THE SAMPLE. NO OTHER BURRS/ANOMALIES WERE FOUND. THE CHIP WRAP CAN BE SEEN WITH THE NAKED EYE.