BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    MDR report key: 2834803 · Received November 16, 2012

    Report

    Report Number
    8030965-2012-01269
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATED THE DEVICE; THE SCREWDRIVER TIP BROKE OFF DUE TO EXCESSIVE MECHANICAL FORCE DURING INSERTION. THE SCREW HEAD ITSELF IS BADLY DAMAGED. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOWS CONFORMITY TO THE SPECIFICATIONS. THE BROKEN SURFACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE WHILE INSERTING A SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF. THE BROKEN TIP IS STUCK IN THE SCREW. IT WAS REPORTED THE SURGEON WAS TIGHTENING IN A NORMAL MANNER. THE SURGEON WAS ABLE TO USE A ROD HOLDER TO REMOVE THE SCREW. ALL BROKEN FRAGMENTS WERE RETRIEVED. THERE WAS NO IMPLANT TO THE PATIENT. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 10 TO 15 MINUTES. THIS EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BIHEX Ø3 W/T-HANDLE SCREWDRIVER HWC SYNTHES GMBH 1391941

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR