BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SMALL HEXAGONAL SCREWDRIVER

    MDR report key: 3626355 · Received February 13, 2014

    Report

    Report Number
    3003787298-2014-00009
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6) A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR WAS REVIEWED AND (B)(4) WAS FOUND ON (B)(4) LOT #5052063 FOR FEATURE L1 OVERSIZE. THE QE ACCEPTED THE PARTS CONFORMS AFTER RE-INSPECTION USING GAGE PIN AND CALIPER. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE ISSUE IS ON THE HANDLE COMPONENT NOT THE TIP OF THE SHAFT THAT BROKE. NO ISSUES WERE FOUND DURING MANUFACTURE THAT CONTRIBUTED TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH CLICK'X ON A UNKNOWN DATE. LATER, IT WAS DISCOVERED THAT THE PATIENT FELL AND WAS SUSPECTED TO HAVE PSEUDARTHROSIS AT L5-S1. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 AND CLICK'X WAS EXPLANTED AND EXPEDIUM WAS IMPLANTED INTO THE PATIENT AT LEVELS T8 TO THE PELVIS. DURING THE REMOVAL OF THE TRANSCONNECTOR, THE TIP OF THE DRIVER SHEARED OFF. THE RESCUE DRIVER BECAME STUCK IN THE HANDLE AT THE END OF THE CASE. THE IMPLANT AND INSTRUMENT WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96294 LONG SMALL HEXAGONAL SCREWDRIVER HXX SYNTHES JENNERSVILLE 5188431

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female