BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT

    MDR report key: 7946177 · Received October 9, 2018

    Report

    Report Number
    9680825-2018-00085
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    July 19, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Removal / Correction Number
    9680825-09-27-2018-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DRILL BIT CODE 1-1100201 LOT 289814 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 259 DEVICES. 249 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. TECHNICAL EVALUATION: THE RETURNED DRILL BIT, RECEIVED ON SEPTEMBER 12TH, 2018, WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE DRILL BIT IS DIRTY. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK WAS PERFORMED ON THE RETURNED DEVICE COMPARED TO DRILL BITS TAKEN FROM THE STOCK. IT WAS CONFIRMED THAT THE RETURNED DRILL BIT HAS A LOWER CUTTING PERFORMANCE THAN THE DRILL BITS HISTORICALLY MANUFACTURED. FINAL COMMENTS: ORTHOFIX HAS RECEIVED SOME COMPLAINTS FROM THE MARKET OF A LOWER CUTTING PERFORMANCE OF DRILL BITS. ORTHOFIX (B)(4) CONDUCTED AN INVESTIGATION BY PERFORMING TECHNICAL ANALYSIS, MEDICAL EVALUATIONS AND A REVIEW OF THE RISK ANALYSIS. THE RESULT OF THE INVESTIGATION DETERMINED THAT SOME PRODUCTION BATCHES OF DRILL BITS, MANUFACTURED IN A LIMITED PERIOD OF THE YEARS 2017/2018, SHOW A LOWER CUTTING PERFORMANCE COMPARED TO DRILL BITS HISTORICALLY MANUFACTURED. ORTHOFIX DETERMINED THAT ALL DRILL BITS MANUFACTURED IN THAT LIMITED PERIOD OF TIME BE WITHDRAWN FROM THE MARKET (REF: US FDA RECALL ACTION NUMBER 9680825-09-27-2018-003-R AND ORTHOFIX (B)(4) REF: (B)(4). ORTHOFIX (B)(4) WOULD LIKE TO INFORM YOU THAT THE DEVICE INVOLVED IN THIS EVENT, BELONGS TO A BATCH INCLUDED IN THE RECALLED LIST. ORTHOFIX (B)(4) WOULD LIKE TO ASSURE THAT DRILL BITS MANUFACTURED BEFORE AND AFTER THE INDICATED PERIOD HAVE OPTIMAL CUTTING PERFORMANCE. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    HE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: (B)(4), BATCH NUMBER: 289814, HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON NAME: DR. (B)(6), DATE OF INITIAL SURGERY: (B)(6) 2018, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: CORRECTION, PATIENT'S INFORMATION: (B)(6), FEMALE, (B)(6), HEIGHT NOT KNOWN, PREVIOUS HEALTH CONDITION: CONGENITAL SHORT FEMUR, PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: L) FEMORAL LRS DEFORMITY CORRECTION + 8 PLATE INSERTION: SURGEON TRIED TO DRILL BUT THE DRILL WAS NOT ADVANCING, AND THE DRILL BIT STARTED TO BURN THE BONE. THE SURGEON THEN SWAPPED DRILL BIT TO 1-1100701 4.8MM X 280MM AND IT WORKED FINE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: USED A 280MM X 4.8MM DRILL BIT 1-1100701. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: STILL IN SITU - CORRECTION STILL ON-GOING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790904 DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT JDW ORTHOFIX SRL 1-1100201 289814

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention