BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCL-CABLE W/CRIMP Ø1.7 SST

    MDR report key: 2874617 · Received December 15, 2012

    Report

    Report Number
    1719045-2012-01377
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    K992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. TYPICAL MARKS COULD BE DOCUMENTED AT THE CABLES, THERE WERE THREE MARKS CERTAINLY FROM THE TENSION HOLDER. THE DAMAGE AT THE CABLES WERE PROBABLY INITIATED FROM THE CRIMPING WITH THE CABLE CRIMPER. THE MICROSTRUCTURE OF THE USED MATERIAL WAS EXAMINED IN A CROSS SECTION AND FOUND TO BE ACCORDING TO THE STANDARDS. THE CABLES ARE MANUFACTURED FROM STAINLESS STEEL, WHICH IS SPECIFIED AS SURGICAL IMPLANT MATERIAL IN THE STANDARD ISO 5832-1 AND THE ASTM F-138. ALL RAW MATERIAL USED FOR IMPLANTS UNDERGO AN INTENSE AND SYSTEMATIC MATERIAL ACCEPTANCE TESTING AND ARE RELEASED FOR MANUFACTURE ONLY AFTER COMPLIANCE WITH THE INTERNATIONAL NORMS AND AO SPECIFICATIONS HAS BEEN ESTABLISHED. THE PRESENT CABLE BROKE MOST PRESUMABLY BECAUSE OF DEFORMATION, PARTIAL CUTTING AND RESULTING OVERLOAD.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: DURING A CERCLAGE FOR DISTAL FRACTURE OF FEMUR PROCEDURE, TWO CABLES BROKE DURING TIGHTENING. REPORTEDLY THE PRESSURE WAS LESS THAN 40 NM. THE SURGEON HAD TO RESTART THE TWO CERCLAGES IN ORDER TO OBTAIN A SATISFACTORY STABILITY OF THE REDUCTION WITH TWO OTHER CABLES. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERCL-CABLE W/CRIMP Ø1.7 SST CERCL-CABLE W/CRIMP JDQ SYNTHES MONUMENT P123722

    Patients

    Seq Age Sex Outcome Treatment
    1 CERCL-CABLE W/CRIMP