BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER 3.5 T15 W/GROOVE L200

    MDR report key: 2781857 · Received October 11, 2012

    Report

    Report Number
    8030965-2012-01027
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE SCREWDRIVER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE TIP OF THE SCREWDRIVER WAS STRONGLY TWISTED BEFORE IT BROKE. THIS IS AN INDICATION THAT TOO MUCH TORQUE, FAR OVER THE CALCULATED DESIGN, WAS APPLIED ONTO THIS DEVICE AND THAT A MECHANICAL OVERLOAD CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE WHILE REMOVING A 3.5MM LOCKING SCREW, THE EDGE OF THE SCREWDRIVER BROKE. THE ACCOUNT COULD NOT FIND THE BROKEN FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRDRIVER 3.5 T15 W/GROOVE L200 SCRDRIVER 3.5 T15 W/GROOVE L200 HXX SYNTHES GMBH 1485283

    Patients

    Seq Age Sex Outcome Treatment
    1