BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM DRILL BIT/QC/165MM

    MDR report key: 6888108 · Received September 22, 2017

    Report

    Report Number
    9612488-2017-10480
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Report Date
    September 1, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    UDI-DI
    07611819245891
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. PART 310.284 / #LOT 8792588 / LCP DRILL BIT Ø 2.8 MM WITH STOP / MANUF.DATE: JANUARY 2014. THE INVESTIGATION OF THE COMPLAINED DRILL BIT SHOWS THAT THE TIP AND THE CUTTING EDGES ARE ROUNDED AND WORN. BECAUSE OF THE DAMAGES THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOTS IN QUESTION. THE MEASURABLE DIMENSIONS ARE WELL DOCUMENTED AND ALL WITHIN THE VALID SPECIFICATIONS. WE ASSUME THE PRODUCT WAS AN OFTEN AND INTENSIVE USED INSTRUMENT AND THE COMPLAINT CONDITION WAS CAUSED BY REGULAR WEAR DURING ITS 3 YEARS OF LIFESPAN. IN THIS REGARD, WE WOULD LIKE TO DRAW YOUR ATTENTION ON PAGE 4 IN THE LEAFLET ¿IMPORTANT INFORMATION¿: CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. BASED ON THE MANUFACTURING INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE. DEVICE WORN FROM NORMAL USE AND SERVICING. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER PHONE NUMBER IS (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 310.284, LOT # 8792588: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 06.JAN.2014: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UPON RECEIPT OF THE LOAN SET FROM DISTRIBUTOR, IT WAS IDENTIFIED THAT THE DRILL BIT IS BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM DRILL BIT/QC/165MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666559 2.8MM DRILL BIT/QC/165MM BIT,DRILL HTW SYNTHES BETTLACH 8792588 07611819245891

    Patients

    Seq Age Sex Outcome Treatment
    1