BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS

    MDR report key: 3003370 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10387
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 29, 2011
    Report Date
    May 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD¿L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES. MFG VISUAL EVAL NOTED ON THE RETURNED SAMPLE, THAT THE SET SCREW THAT HOLDS THE RIM IN POSITION WAS MISSING. THE INVESTIGATION FOUND THAT THE CONNECTOR FELL APART BECAUSE THE SET SCREW WAS MISSING. HOWEVER, A CAUSE FOR THIS OCCURENCE COULD NOT BE DETERMINED SINCE THE SET SCREW WAS NOT SENT BACK FOR INVESTIGATION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION INTERBODY FUSION (ORIF) PROXIMAL FEMUR PROCEDURE, THE SURGEON RAN THE DRILL BACKWARDS AND IT WAS DISCOVERED THE SET SCREW THAT HOLDS THE ASSEMBLY HAD FALLEN OUT. THE ASSEMBLY WAS USED TO COMPLETE THE PROCEDURE. THE SET SCREW WAS MISSING WHEN THE PROCEDURE BEGAN, NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86955 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS HTO SYNTHES GMBH 4775234

    Patients

    Seq Age Sex Outcome Treatment
    1