BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP CBL DIA2 SS & CABLE SLEEVE

    MDR report key: 5808835 · Received July 20, 2016

    Report

    Report Number
    3006946279-2016-00238
    Event Type
    Injury
    Date Received
    July 20, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 20, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDQ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT DISTRIBUTED OR MANUFACTURED IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K982545.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE REVIEW OF MANUFACTURING HISTORY INDICATES THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE CABLE FRACTURE CLOSE TO THE CIRCLING BUCKLE. ACCORDING TO THE AVAILABLE DATA, THE DEVICE WAS USED IN A KNEE SURGERY FOR A PATELLAR TENDON STRAPPING WHICH IS NOT A CLAIM OF THE PRODUCT. ACCORDING TO THE PACKAGE INSERT, UNDER INDICATIONS IT STATES, "THE CERCLAGE CABLES AND CRIMPING BAR ARE INDICATED FOR THE CERCLAGE OF BONE AND FOR THE ALIGNMENT AND STABILIZATION OF FRACTURES AND OSTEOTOMIES OF LONG BONES, EITHER SEPARATELY OR IN ASSOCIATION WITH OTHER OSTEOSYNTHESIS DEVICES. THE CABLES ARE INTENDED FOR MAINTAINING THE ALIGNMENT OF A FRACTURE OR OSTEOTOMY UNTIL CONSOLIDATION AND ARE NOT DESIGNED TO WITHSTAND LOADING STRESSES WITHOUT ADDITIONAL SUPPORT." A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A KNEE PROCEDURE TO REMOVE A FRACTURED CERCLAGE CABLE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462120 IMP CBL DIA2 SS & CABLE SLEEVE CERCLAGE, FIXATION JDQ BIOMET FRANCE S.A.R.L. N/A 0001018069

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R