ANCHOR BOLT - LSB STYLE

Additional Manufacturer Narrative

AS STATED IN THE EVENT DESCRIPTION SECTION, AD-TECH RESPONDED BACK TO THE DISTRIBUTOR THE DAY THEY WERE NOTIFIED TO OBTAIN ADDITIONAL INFORMATION. TO DATE, THE DISTRIBUTOR 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 ELEVEN SIMILAR COMPLAINTS FOR ANCHOR BOLTS BREAKING BETWEEN (B)(6) 2016 AND (B)(6) 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. NEITHER A BATCH RECORD REVIEW NOR A PRODUCT RETURN ANALYSIS COULD BE PERFORMED FOR THIS COMPLAINT AS NO LOT INFORMATION HAS BEEN GIVEN THUS FAR. THE INVESTIGATION IS STILL ON-GOING AS AD-TECH IS AWAITING FURTHER INFORMATION FROM THE DISTRIBUTOR/CUSTOMER.

Description of Event or Problem

ON 6/5/2018, THE AD-TECH CLINICAL SPECIALIST RECEIVED AN EMAIL FROM ONE OF THEIR DISTRIBUTORS STATING THAT THEY HAD RECEIVED A REPORT OF FRACTURED BOLTS FROM ONE OF THEIR CUSTOMERS. AD-TECH RESPONDED BACK TO THE DISTRIBUTOR THE DAY THEY WERE NOTIFIED TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE DISTRIBUTOR HAS NOT RESPONDED BACK. IT IS UNKNOWN WHAT THE OUTCOME OR CURRENT STATUS IS OF THE PATIENT. A SUPPLEMENT REPORT WILL BE INITIATED SHOULD AD-TECH RECEIVE ADDITIONAL INFORMATION RELEVANT TO THIS MEDWATCH REPORT.

Additional Manufacturer Narrative

AS STATED IN THE EVENT DESCRIPTION SECTION, AD-TECH RESPONDED BACK TO THE DISTRIBUTOR THE DAY THEY WERE NOTIFIED TO OBTAIN ADDITIONAL INFORMATION. TO DATE, THE DISTRIBUTOR 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 12 SIMILAR COMPLAINTS FOR ANCHOR BOLTS BREAKING BETWEEN 1/1/2016 AND 5/25/2018. 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. NEITHER A BATCH RECORD REVIEW NOR A PRODUCT RETURN ANALYSIS COULD BE PERFORMED FOR THIS COMPLAINT AS NO LOT INFORMATION HAS BEEN GIVEN THUS FAR. THE INVESTIGATION IS STILL ON-GOING AS AD-TECH IS AWAITING FURTHER INFORMATION FROM THE DISTRIBUTOR/CUSTOMER. UPDATED: 9/21/2018 THE FOLLOWING LOT INFORMATION WAS RECEIVED FROM THE CUSTOMER. LOT INFORMATION FOR ALL ANCHOR BOLTS USED IN THE CASE HAD BEEN GIVEN. IT IS UNKNOWN WHICH LOTS EXPERIENCED THE BREAKAGES. BATCH NUMBER CATALOG NUMBER LSBK1-BX-05 LOT NUMBER 208140645 BATCH NUMBER 0110203 UDI (B)(4). CATALOG NUMBER LSBK1-BX-05 LOT NUMBER 208140653 BATCH NUMBER 0113053 UDI (B)(4). CATALOG NUMBER LSBK1-BX-05 LOT NUMBER 208140655 BATCH NUMBER 0114355 UDI (B)(4). CATALOG NUMBER LSBK1-AX-05 LOT NUMBER 208140656 BATCH NUMBER 0114693 UDI (B)(4). NO RETURN ANALYSIS COULD BE CONDUCTED AS NO PRODUCT WAS RETURNED FOR EVALUATION. DHR REVIEWS FOR ALL ANCHOR BOLT LOTS INVOLVED IN THE CASE WERE PERFORMED AS THE CUSTOMER WAS UNABLE TO SPECIFICALLY IDENTIFY WHICH LOTS WENT WITH WHICH BOLTS. WORK ORDER 110203 FROM LOT 208140645 WAS REVIEWED. 76 ANCHOR BOLT KITS WERE PLANNED FOR THIS WORK ORDER AND 76 WERE COMPLETED. THERE WERE 35 POUCHES OPENED FOR LINT. HOWEVER, THIS ISSUE WILL NOT CONTRIBUTE OR CAUSE THE REPORTED COMPLAINT. 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. WORK ORDER 113053 FROM LOT 208140653 WAS REVIEWED. 75 ANCHOR BOLT KITS WERE PLANNED FOR THIS WORK ORDER AND 75 WERE COMPLETED. THERE WERE 21 BAGS OPENED DURING LINT. HOWEVER, THIS ISSUE WILL NOT CONTRIBUTE OR CAUSE THE REPORTED COMPLAINT. 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. WORK ORDER 114355 FROM LOT 208140655 WAS REVIEWED. 50 ANCHOR BOLT KITS WERE PLANNED FOR THIS WORK ORDER AND 50 WERE COMPLETED. THERE WERE 11 POUCHES OPENED FOR LINT. HOWEVER, THIS ISSUE WILL NOT CONTRIBUTE OR CAUSE THE REPORTED COMPLAINT. 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. WORK ORDER 114693 FROM LOT 208140656 WAS REVIEWED. 50 ANCHOR BOLT KITS WERE PLANNED FOR THIS WORK ORDER AND 49 WERE COMPLETED. THERE WERE 19 POUCHES OPENED FOR LINT AND 1 NMR DUE TO FOREIGN MATERIAL DURING FINISHED GOODS PACKAGING. HOWEVER, THIS ISSUE WILL NOT CONTRIBUTE OR CAUSE THE REPORTED COMPLAINT. THERE WERE NO ADDITIONAL ISSUES NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT AND 49 KITS PASSED THE IN-PROCESS AND FINAL QC CHECKS. FURTHER INVESTIGATION WAS CONDUCTED TO LOOK INTO THE ANCHOR BOLT SUPPLIERS FOR THE 2016 TO PRESENT COMPLAINTS REGARDING "ANCHOR BOLTS BREAKING". IT WAS FOUND THAT MOST IMPACTED BOLTS CAME FROM AD-TECH'S PREVIOUS SUPPLIER (INTEGRATED MEDICAL SOLUTIONS (IMS)). HOWEVER, BOLTS IDENTIFIED IN THIS CURRENT COMPLAINT INDICATED THAT THE BOLTS CAME FROM 2 SUPPLIERS, IMS AND AD-TECH'S CURRENT SUPPLIER, PRECISION SWISS PRODUCTS (PSP). AN INTERNAL ENGINEERING INVESTIGATION WAS THEN CONDUCTED TO DETERMINE IF THE BREAKAGES WERE SUPPLIER-SPECIFIC. BASED ON THE STUDY, LSBK1- ANCHOR BOLTS FROM IMS AND LSBK1- BOLTS FROM PSP WERE TESTED. TESTING INVOLVED MEASURING THE AMOUNT OF STRENGTH IT TOOK TO BEND THE BOLTS. BOLTS FROM BOTH IMS AND PSP PORTRAYED NO SIGNIFICANT DIFFERENCE IN STRENGTH, THUS INDICATING THAT THIS ISSUE WAS NOT SUPPLIER-SPECIFIC. BASED ON THIS INFORMATION IN ADDITION TO NOT BEING ABLE TO CONFIRM THE ALLEGED DEFICIENCY, THE CAUSE FOR THIS ISSUE IS DEEMED INCONCLUSIVE. AN ANALYSIS OF ALL ANCHOR BOLT BREAKAGE COMPLAINT DATA WAS ALSO CONDUCTED. THE CURRENT RATE OF ANCHOR BOLT BREAKAGE COMPLAINTS VERSUS PRODUCTS SOLD IS VERY LOW; 0.08% OVER THE PAST 2 YEARS. PER THE RISK ASSESSMENT, THE RISK REMAINS ALAP (AS LOW AS POSSIBLE). THE OCCURRENCE VALUE EXCEEDS THE VALUE PRESENT IN RMF-4015. THE RISK FILE WAS UPDATED THROUGH ENGINEERING CHANGE NOTICE 6079 (RELEASED AUGUST 15, 2018). AS STATED IN RMF-4005-4, ALL INDICATED USES OF THE DEVICE HAVE MITIGATED RISKS THAT ARE DETERMINED TO BE ALAP. IN VIEW OF THE COMPLETE ANALYSIS, THE BENEFITS OUTWEIGH THE RISKS. NO FURTHER RISK MITIGATIONS ARE AVAILABLE AT THIS TIME. BASED ON THIS, NO CORRECTIVE ACTIONS WILL BE IMPLEMENTED AS PART OF THIS COMPLAINT. THE COMPLAINT WAS CLOSED, AND THE ISSUE IS BEING MONITORED MOVING FORWARD.

Description of Event or Problem

ON 6/5/2018, THE AD-TECH CLINICAL SPECIALIST RECEIVED AN EMAIL FROM ONE OF THEIR DISTRIBUTORS STATING THAT THEY HAD RECEIVED A REPORT OF FRACTURED BOLTS FROM ONE OF THEIR CUSTOMERS. AD-TECH RESPONDED BACK TO THE DISTRIBUTOR THE DAY THEY WERE NOTIFIED TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE DISTRIBUTOR HAS NOT RESPONDED BACK. IT IS UNKNOWN WHAT THE OUTCOME OR CURRENT STATUS IS OF THE PATIENT. A SUPPLEMENT REPORT WILL BE INITIATED SHOULD AD-TECH RECEIVE ADDITIONAL INFORMATION RELEVANT TO THIS MEDWATCH REPORT.