BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR BOLT-LSB STYLE

    MDR report key: 7441803 · Received April 18, 2018

    Report

    Report Number
    2183456-2018-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Report Date
    September 20, 2018
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GCZ
    UDI-DI
    90841823104260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 NINE SIMILAR COMPLAINTS FOR ANCHOR BOLTS BREAKING BETWEEN 1/1/2016 AND 3/19/2018. 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. AS STATED, 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, 33 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, 73 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. THE UDI NUMBER FOR LOT 208140643 WAS LISTED. THE UDI NUMBER FOR LOT 208140644 IS AS FOLLOWS: (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. UPDATED: 9/20/2018: AN INVESTIGATION WAS CONDUCTED TO LOOK INTO THE ANCHOR BOLT SUPPLIERS FOR THE 2016 TO PRESENT COMPLAINTS REGARDING "ANCHOR BOLTS BREAKING". OUT OF THE 14 COMPLAINTS RECEIVED, 10 WERE CONFIRMED TO BE FROM BOLTS SUPPLIED BY (B)(4), AND THE REMAINING 4 COMPLAINTS DID NOT HAVE PRODUCT INFORMATION, THUS THE SUPPLIERS COULD NOT BE CONFIRMED. IT IS POSSIBLE THAT THE REMAINING 4 COMPLAINTS COULD HAVE BEEN FROM OTHER SUPPLIERS, BUT THIS COULD NOT BE DETERMINED. THIS MEANS THAT 71.43% OF ANCHOR BOLT COMPLAINTS ARE CONFIRMED TO BE FROM (B)(4). IN ADDITION TO THIS, 37% OF THE ANCHOR BOLTS ISSUED FROM 2016 TO PRESENT WERE (B)(4). THE PROBABILITY OF THIS OCCURRING AT RANDOM IS LESS THAN 1%. GIVEN THE SIGNIFICANCE OF THIS DATA, IT IS PROBABLE THAT THE ISSUE OF BOLTS BREAKING IS LINKED TO (B)(4). (B)(4) IS NO LONGER A SUPPLIER OF AD-TECH MEDICAL, AS THEY WERE DISQUALIFIED ON MARCH 8, 2018. THERE ARE NO BOLTS IN STOCK FROM (B)(4), AND THE LAST ORDER WITH THEM WAS PLACED IN JANUARY OF 2017. PER THE RISK ASSESSMENT, THE RISK LEVEL REMAINS ALAP (AS LOW AS POSSIBLE). ALL ANCHOR BOLT PRODUCTS WERE EVALUATED TO OBTAIN THE MEAN ANNUAL CLINICAL USES. ALL COMPLAINTS IDENTIFIED THROUGH THE HISTORICAL COMPLAINT REVIEW WERE CONSIDERED DURING OCCURRENCE CALCULATIONS, SINCE NONE REFUTED THE REPORTED DEFICIENCY. HOWEVER, ONLY ONE COMPLAINT HAD A RETURN ANALYSIS WHICH SUPPORTED THE ALLEGED DEFICIENCY. THE OCCURRENCE VALUE REMAINS THE SAME AND NO ADDITIONAL CHANGES ARE REQUIRED WITHIN RMF-4015-UFMEA ANCHOR BOLT-UFMEA. 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 THUS NO CORRECTIVE ACTIONS WILL BE IMPLEMENTED AS PART OF THE COMPLAINT. THE DEVICE MALFUNCTION DID NOT CAUSE A DEATH OR SERIOUS INJURY NOR WOULD IT CAUSE A DEATH OR SERIOUS INJURY SHOULD IT RECUR. BASED ON THIS INVESTIGATION, THIS COMPLAINT WAS CLOSED AND THE ISSUE IS BEING MONITORED MOVING FORWARD. CLOSE ATTENTION WILL BE PAID TO THE SUPPLIERS OF ANY BOLTS BREAKING.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE AD-TECH CLINICAL SPECIALIST RECEIVED AN EMAIL FROM A DISTRIBUTOR STATING THAT THEY WERE INFORMED BY ONE OF THEIR CUSTOMERS THAT AN AD-TECH ANCHOR BOLT BROKE AFTER IMPLANTATION. AD-TECH RESPONDED BACK TO THE CUSTOMER THAT DAY TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE CUSTOMER 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 · 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.

    Description of Event or Problem · 1

    ON 3/19/2018, THE AD-TECH CLINICAL SPECIALIST RECEIVED AN EMAIL FROM A DISTRIBUTOR STATING THAT THEY WERE INFORMED BY ONE OF THEIR CUSTOMERS THAT AN AD-TECH ANCHOR BOLT BROKE AFTER IMPLANTATION. AD-TECH RESPONDED BACK TO THE CUSTOMER THAT DAY TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE CUSTOMER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283645 ANCHOR BOLT-LSB STYLE ANCHOR BOLT-LSB STYLE GCZ AD-TECH MEDICAL INSTRUMENT CORP. 208140643 OR 208140644 90841823104260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other