ANCHOR BOLT - LSB STYLE

Additional Manufacturer Narrative

AN INTERNAL COMPLAINT INVESTIGATION WAS PERFORMED FOR THIS ISSUE. SPECIFICALLY, A HISTORICAL COMPLAINTS REVIEW WAS COMPLETED FOR THE ALLEGED DEFICIENCY "BROKEN ANCHOR BOLTS". THERE HAVE BEEN THIRTEEN SIMILAR COMPLAINTS FOR ANCHOR BOLTS BREAKING BETWEEN JANUARY 1, 2016 AND AUGUST 14, 2018. A CAPA AND INVESTIGATION REVIEW WAS ALSO CONDUCTED FOR THE ALLEGED DEFICIENCY "ANCHOR BOLTS (2) BROKE-1 DURING & 1 AFTER IMPLANTATION" AND THERE HAVE BEEN NO CAPAS OR INVESTIGATIONS OPENED FOR THIS ISSUE TO DATE. A BATCH RECORD REVIEW WAS CONDUCTED; 50 LSBK1-AX-05 ANCHOR BOLTS WERE PLANNED FOR THIS WORK ORDER AND 50 WERE COMPLETED. NO ISSUES WERE NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT. THE 50 LSBK1-AX-05 ANCHOR BOLTS PASSED THE IN-PROCESS AND FINAL QC CHECKS. NO PRODUCT RETURN ANALYSIS COULD BE PERFORMED FOR THIS COMPLAINT AS NO PRODUCT WAS RETURNED. THE RISK LEVEL FOR THIS ISSUE REMAINS ALAP (AS LOW AS POSSIBLE). ADDITIONALLY, BASED ON A REVIEW OF PREVIOUS COMPLAINTS FOR ANCHOR BOLT BREAKAGES AND AN ANALYSIS OF ALL ANCHOR BOLT BREAKAGE COMPLAINT DATA, THE CURRENT RATE OF ANCHOR BOLT BREAKAGE COMPLAINTS VERSUS PRODUCTS SOLD IS VERY LOW; (B)(4)% OVER THE PAST 2 YEARS. AD-TECH IS CONTINUING TO MONITOR THIS ISSUE CLOSELY.

Description of Event or Problem

ON AUGUST 14, 2018 AD-TECH'S CLINICAL SPECIALIST RECEIVED A PHONE CALL FROM A CUSTOMER STATING THAT 2 ANCHOR BOLTS HAD SHEARED OFF AT THE THREADS. ONE BOLT HAD SHEARED OFF WHILE BEING SCREWED INTO THE SKULL DURING IMPLANTATION AND THE NEUROSURGEON DRILLED OUT THE THREADED PORTION. THE SECOND SHEARED BOLT WAS FOUND 6 DAYS POST-OP. THE THREADS STILL REMAIN IN THE SKULL AND WILL BE DRILLED OUT DURING EX-PLANTATION. TO DATE, IT IS UNKNOWN WHAT THE CURRENT STATUS IS OF THE PATIENT. IT WAS STATED THAT SPECIFIC TO THE SHEARED BOLT SEEN DURING IMPLANTATION, THE TRAJECTORY WAS SCRAPPED AND RE-PLANNED.