BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/DHS/DCS-WRENCH NO. 338.300

    MDR report key: 3160555 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-03040
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    June 18, 2012
    Report Date
    June 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SINCE NO MANUFACTURING RELATED CONDITION WAS FOUND WE HAVE TO ASSUME THAT AN INSUFFICIENT CONNECTION WITH THE DHS SCREW DURING PREPARATION HAS LED TO THESE BREAKAGES. THE DAMAGED SCREW, RECESS WITHOUT TABS, HAS NOT BEEN RETURNED IN ORDER TO INVESTIGATE FURTHER. NO PRODUCT FAULT COULD BE DETECTED THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE.

    Description of Event or Problem · 1

    SCREWS ARE BROKEN OFF DURING PREPARATION. THE ORTHOPEDIC REGISTER WAS CONNECTING THE LAG SCREW TO THE WRENCH WHEN HE TIGHTENED THE CONNECTING THE LAG SCREW THE THREADED TIP BROKE OFF. THE REGISTRAR THEN CONNECTED THE SECOND CONNECTION SCREW AS HE TIGHTENED THE SCREW AND THEN INSERTED THE LAG SCREW THE CONNECTION SCREW BROKE AGAIN. THE SURGEON INSERTED THE REST OF THE LAG SCREW WITH THE REMOVAL WRENCH WITHOUT ISSUE. THE SYNTHES DYNAMIC HIP SYSTEM (DHS) WRENCH WAS SUITABLE FOR THE OTHER RECESSED LAG SCREW. THE LAG SCREW OCTAGONAL COUPLING APPEARED TO HAVE BEEN USED BY THE HOSPITAL INSTEAD OF THE DHS SCREW. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261059 CONNECSCR F/DHS/DCS-WRENCH NO. 338.300 HWB SYNTHES GMBH 3739720

    Patients

    Seq Age Sex Outcome Treatment
    1