BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 L80 2FLUTE

    MDR report key: 3100125 · Received May 8, 2013

    Report

    Report Number
    8030965-2013-02136
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 11, 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION OF THE COMPLAINED DRILL BIT SHOWS THAT THE TIP IS TWISTED DUE TO MECHANICAL MISHANDLING WHILE USE. VISIBLE SIGNS INDICATE THAT THE DRILL BIT BECAME BLOCKED; FURTHER APPLIED HIGH MECHANICAL FORCE CAUSED THE DEFORMATION. THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A SURGEON REPORTED A DEFECT IN THE DRILL BIT. THE SPACING OF THE CUT EDGE AT THE DRILL BIT WAS NOT EQUAL. THIS WAS DISCOVERED BEFORE USE ON (B)(6) 2013, NOT DURING AN OPERATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202101 DRILL BIT Ø1.5 L80 2FLUTE HTW SYNTHES GMBH F-10847

    Patients

    Seq Age Sex Outcome Treatment
    1