BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROX TIBPI 3.5 LAT LE SHAFT 6HO L107

    MDR report key: 2831453 · Received October 11, 2012

    Report

    Report Number
    3003506883-2012-00322
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 14, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE COMPLAINT LCP PLATE WAS FORWARDED TO THE RESPONSIBLE PRODUCT DEVELOPMENT CENTER FOR INVESTIGATION. THE INVESTIGATION HAS SHOWN THAT THE THREAD HOLES OF THE LCP PLATE CAN CUT THE USPU-THREADS. THE REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE BORDERS OF THE HOLES OF THE LCP PLATES ARE SHARP. WHEN RUNNING THREADS/WIRE THROUGH THE HOLES (PROXIMAL) THE THREADS ARE GETTING PEELED, STRIPPED AND/OR TORN OFF. THIS IS 3 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PROX TIBPI 3.5 LAT LE SHAFT 6HO L107 LCP PROXTIBPLATE HRS SYNTHES ELMIRA 6709175

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE| SCREW| WIRE