BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø17 CANN F/PFNA

    MDR report key: 3152165 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02766
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE DRILL BIT WAS RECEIVED IN TWO PIECES AND WAS BROKEN AT THE DRILL CHUCK. ACCORDING TO THE MANUFACTURING EVALUATION THE RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE. ACCORDING TO THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL WAS USED AND THE HARDNESS WAS WITHIN SPECIFICATIONS. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED. IT CAN ONLY BE ASSUMED THAT A MECHANICAL OVERLOAD OCCURRED CAUSED THE BREAKAGE DUE TO EXTREMELY HARD BONE AS MENTIONED IN THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED: THIS INSTRUMENT BROKE DURING SURGERY. THE PATIENT HAD A TUMOUR IN THE BONE. THE BONE WAS EXTREMELY HARD AND THE DRILL BIT BROKE INTO 2 PIECES WHILST DRILLING. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252932 DRILL BIT Ø17 CANN F/PFNA HTW SYNTHES GMBH F-10281

    Patients

    Seq Age Sex Outcome Treatment
    1