BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE-STRAIGHT BROACH

    MDR report key: 4950753 · Received July 29, 2015

    Report

    Report Number
    0002249697-2015-02514
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 7, 2015
    Report Date
    February 6, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: THE RETURNED DEVICE WAS SHIPPED TO THE SUPPLIER, GREATBATCH MEDICAL, FOR EVALUATION. THE SUPPLIER CONFIRMED THE EVENT CONCLUDING, "THE MISSING PIN IS THE CAUSE OF THE DEVICE BEING UNABLE TO LATCH ONTO BROACHES BUT THE CAUSE OF THE WELD BREAKAGE AND PIN MISSING IS UNKNOWN." THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE NOT RETURNED FOR EVALUATION. AN EVENT REGARDING A NON FUNCTIONAL INSTRUMENT DUE TO SUBCOMPONENT LOOSENING INVOLVING A RESTORIS BROACH HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICE WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    PART OF ONE OF OUR BROACH HANDLES BECAME DISASSEMBLED DUE TO LOCKING SCREW LOOSENING. ALL PIECES RECOVERED.

    Description of Event or Problem · 1

    PART OF ONE OF OUR BROACH HANDLES BECAME DISASSEMBLED DUE TO LOCKING SCREW LOOSENING. ALL PIECES RECOVERED.

    Description of Event or Problem · 1

    PART OF ONE OF OUR BROACH HANDLES BECAME DISASSEMBLED DUE TO LOCKING SCREW LOOSENING. ALL PIECES RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494854 HANDLE-STRAIGHT BROACH HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG MAKO SURGICAL CORP. 110035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other