BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø4.5/6.5 L450 F/HIP SCREWS F/EXPE

    MDR report key: 3142569 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02596
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED REAMER SHOWS THAT THE TIP IS BROKEN OFF AND THE CUTTING EDGES ARE USED. THE ARTICLE WAS ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATION. NO ABNORMAL FINDINGS WERE IDENTIFIED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A BONE CALCIFICATION BY BISPHOSPHONATES. DURING THE PROCEDURE ON (B)(6) 2013, THE REAMER FOR THE INSERT OF A HIP SCREW WAS BROKEN DURING DRAWING OUT. THE BONE WAS HARD, SO THE SURGEON IMPRESSED A FORCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244623 REAMER Ø4.5/6.5 L450 F/HIP SCREWS F/EXPE LXH SYNTHES GMBH U134816

    Patients

    Seq Age Sex Outcome Treatment
    1