BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, DRILL SLEEVE GUIDE AND LEKSELL GUIDE BLOCK

    MDR report key: 7075238 · Received December 1, 2017

    Report

    Report Number
    2183456-2017-00012
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 3, 2017
    Report Date
    December 1, 2017
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE EVENT DESCRIPTION, THE DRILL BIT, DRILL GUIDE AND LEKSELL BLOCKS ALL FUSED TOGETHER. BELOW IS THE PRODUCT INFORMATION FOR EACH PIECE: CATALOG NUMBER: LK-GB-N-13, DESCRIPTION: LEKSELL GUIDE BLOCK, LOT NUMBER: 715001, (B)(4); DSG-6.3-090-2.4N, DRILL SLEEVE GUIDE, 716180, (B)(4); DDK2-2.4-30X, DISPOSABLE DRILL KIT, 208140654, (B)(4). BATCH RECORD REVIEWS OF THE 3 PIECES WERE PERFORMED ON 11/22/2017. FOR THE LEKSELL GUIDE BLOCK, 3 GUIDE BLOCKS WERE PLANNED FOR THIS WORK ORDER AND 3 WERE COMPLETED. THERE WERE NO ADDITIONAL ISSUES NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT AND ALL GUIDE BLOCKS PASSED THE IN-PROCESS AND FINAL QC CHECKS. FOR THE DRILL SLEEVE GUIDE, 18 DRILL SLEEVE GUIDES WERE PLANNED FOR THIS WORK ORDER AND 18 WERE COMPLETED. THERE WERE NO ADDITIONAL ISSUES NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT AND ALL DRILL SLEEVE GUIDES PASSED THE IN-PROCESS AND FINAL QC CHECKS. FOR THE DISPOSABLE DRILL KIT, 25 DRILL KITS WERE PLANNED FOR THIS WORK ORDER AND 24 WERE COMPLETED DUE TO A NONCONFORMANCE IDENTIFIED DURING THE MANUFACTURING PROCESS FOR ONE OF THE KITS. THERE WERE NO ADDITIONAL ISSUES NOTED IN THE WORK ORDER PROCESS NOTES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT AND ALL REMAINING KITS PASSED THE IN-PROCESS AND FINAL QC CHECKS. THE PRODUCTS WERE RETURNED FOR EVALUATION. THE EVALUATION AND INVESTIGATION FOR THIS ISSUE ARE STILL ON-GOING.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DURING A LEKSELL FRAME SEEG CASE, THE AD-TECH CLINICAL SPECIALIST WITNESSED THE SURGEON DRILLING HIS FIRST PLANNED TRAJECTORY. AFTER BARELY USING THE DRILL, THE DRILL BIT, DRILL GUIDE AND LEKSELL BLOCKS ALL FUSED TOGETHER. THE SURGEON TRIED TO GET THE PLACEMENT TOOLS APART, BUT THE DRILL AND GUIDE WOULD NOT BUDGE. THE LEKSELL BLOCKS EVENTUALLY CAME APART FROM THE FUSED DRILL BIT AND GUIDE. THERE WAS NO IMPACT TO PATIENT SAFETY AS A RESULT OF THE ISSUE; HOWEVER THE SURGERY WAS CANCELLED AND RESCHEDULED FOR A DIFFERENT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853445 DRILL BIT, DRILL SLEEVE GUIDE AND LEKSELL GUIDE BLOCK PLACEMENT ACCESSORIES HTW AD-TECH MEDICAL INSTRUMENT CORP. REFER TO SECTION H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other