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Patient 1
AS STATED IN THE EVENT DESCRIPTION SECTION, AD-TECH RESPONDED BACK TO THE CUSTOMER THE DAY THEY WERE NOTIFIED TO OBTAIN ADDITIONAL INFORMATION. TO DATE, THE CUSTOMER HAS NOT RESPONDED BACK. THUS, IT IS UNKNOWN WHAT THE OUTCOME/CURRENT STATUS IS OF THE PATIENT. 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 (B)(4) SIMILAR COMPLAINTS FOR ANCHOR BOLTS BREAKING BETWEEN (B)(4)2016 AND (B)(4) 2018. A CAPA AND INVESTIGATION REVIEW WAS ALSO CONDUCTED FOR THE ALLEGED DEFICIENCY "ANCHOR BOLT BROKE AFTER IMPLANTATION" AND THERE HAVE BEEN NO CAPAS OR INVESTIGATIONS OPENED FOR THIS ISSUE TO DATE. TWO LOT NUMBERS (LOT 208140643 OR 208140644) WERE LISTED. THIS IS DUE TO THE CUSTOMER BEING UNSURE OF THE SPECIFIC LOT NUMBER FOR THE IMPACTED BOLT. BASED ON THIS, 2 BATCH RECORD REVIEWS WERE PERFORMED FOR THE IMPACTED PRODUCT ON 4/6/2018 (FOR LOT 208140644, BATCH# 109669) AND 4/13/2018 (FOR LOT 208140643, BATCH# 110042). SPECIFIC TO BATCH# 109669, (B)(4) ANCHOR BOLTS WERE PLANNED FOR THIS WORK ORDER AND 33 WERE COMPLETED. THERE WERE NO ADDITIONAL ISSUES NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT AND ALL KITS PASSED THE IN-PROCESS AND FINAL QC CHECKS. SPECIFIC TO BATCH# 110042, (B)(4) ANCHOR BOLTS WERE PLANNED FOR THIS WORK ORDER AND 71 WERE COMPLETED (2 ANCHOR BOLTS FROM THIS BATCH WERE NONCONFORMING UNRELATED TO THIS ISSUE). THERE WERE NO ADDITIONAL ISSUES NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT AND ALL KITS PASSED THE IN-PROCESS AND FINAL QC CHECKS. (B)(4). THE PRODUCT WAS RETURNED TO AD-TECH ON 3/29/2018 AND A RETURN ANALYSIS WAS COMPLETED. THE ANCHOR BOLT WAS RECEIVED IN A USED AND CONTAMINATED CONDITION WITH NO EVIDENCE OF SUCCESSFUL STERILIZATION. A VISUAL EXAMINATION WAS PERFORMED THROUGH THE PACKAGING IN WHICH THE PRODUCT WAS RECEIVED. THE ANCHOR BOLT BODY WAS FOUND TO BE BROKEN INTO TWO PIECES. THE POINT OF BREAKAGE WAS IN THE THREADED AREA THAT WOULD SCREW INTO THE SKULL. BASED ON THIS INFORMATION, THE COMPLAINT RETURN EVALUATION DOES SUPPORT THE REPORTED ALLEGED DEFICIENCY. A RISK ASSESSMENT WAS PERFORMED AND THE RISK LEVEL IS CONSIDERED ALAP (AS LOW AS POSSIBLE). THE INVESTIGATION IS STILL ON-GOING AS AD-TECH IS AWAITING FURTHER INFORMATION FROM THE DISTRIBUTOR/CUSTOMER.