BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH

    MDR report key: 3142558 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02597
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    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, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED ARTICLES SHOWS THAT THE TWO SCREWDRIVER SHAFTS 313.304 ARE DAMAGED. THE TIPS ARE WORN AND TWISTED. THE SENT PLATE AND THE LOCKING SCREW ARE NOT DAMAGED. WE DISCOVERED THE BROKEN OFF SCREWDRIVER TIP OF ARTICLE 313.304 WHO REMAINS IN THE LOCKING SCREW 402.226S. UNFORTUNATELY WE DID NOT RECEIVE THE COMPLAINED ARTICLE WITH THE BROKEN OFF TIP. WE DO CONCLUDE THAT THE BREAKAGE OCCURRED DUE THE NORMAL USE OF THIS SCREWDRIVER. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE IN ACCORDANCE WITH THE VALID SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A DISTAL HUMERAL FRACTURE. DURING THE DISTAL HUMERAL PLATE OPERATION ON (B)(6) 2013, THE SURGEON TRIED TO INSERTED DISTAL 2.7 MM LOCKING SCREW BY THE TORQUE-SCREWDRIVER. THE SCREWDRIVER HEAD WAS BROKEN AND REMAINED IN THE SCREW HEAD. IT WAS THE FIRST LOCKING, SO THE SURGEON REMOVED THE PLATE AND USED ANOTHER PLATE. HE FELT THE NEXT SCREWDRIVERS HEAD BE WORN OUT. IT WAS REPORTED THAT THE HEAD WAS ACTUALLY TWISTED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243762 SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH HXX SYNTHES GMBH 8154065

    Patients

    Seq Age Sex Outcome Treatment
    1