BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROX-RADIUSPL2.4 LE F/RAD HEAD RIM S

    MDR report key: 2874605 · Received December 15, 2012

    Report

    Report Number
    3003506883-2012-00396
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K040777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.4MM TI LCP RADIAL HEAD WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IT WAS ESTABLISHED THAT INSTEAD OF A LCP SCREW A VA-LCP SCREW WAS USED. WE WOULD LIKE TO POINT OUT THAT YOU EXCESSIVE HAVE TO USE THIS SCREW FOR PROVIDED PLATE. THE CONDUCTED INVESTIGATIONS ACCORDING TO THE MANUFACTURING AND MATERIAL DOCUMENTS HAVE SHOWN THAT THE LCP PLATE WAS MANUFACTURED ACCORDING TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A SURGEON WAS ATTEMPTING TO TIGHTEN 3 SCREWS TO THE PLATE AND DURING THE TIGHTENING PROCESS A SCREW SLIPPED THROUGH THE HOLE IN THE PLATE. THE SURGEON TRIED AGAIN AND AGAIN THE SCREW SLIPPED THROUGH THE PLATE. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PROX-RADIUSPL2.4 LE F/RAD HEAD RIM S LCP PROX-RADIUSPL2.4 LE F/RAD HEAD RIM S HRS SYNTHES ELMIRA 6756399

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR SCREW