BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 4121005 · Received September 26, 2014

    Report

    Report Number
    1818910-2014-28876
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: WITH REGARD TO THE CROSS PIN COMING OUT: (B)(4) CROSS HOLE WAS AMENDED TO BE A THROUGH HOLE. PIN LENGTH CHANGED TO SUIT CROSS HOLE. PIN H7 FIT ADDED. IN 2015, (B)(4) WAS CARRIED OUT TO ASCERTAIN THROUGH DESIGN REVIEW IF ANY PRESENT RISKS COULD BE REDUCED WITHOUT INTRODUCING NEW ONES. THE CROSS HOLE IN THE KNOB IS INTENDED AS AN OPTION FOR THE SURGEON TO INSERT A TOOL AS AN AID TO HELP WITH ROTATION WHEN HAVING SLIPPERY GLOVES. BASED ON THIS REVIEW THERE ARE NO DESIGN IMPROVEMENTS SUGGESTED THAT WOULD DEFINITELY REDUCE THE RISKS ASSOCIATED WITH THESE COMPLAINTS WITHOUT POTENTIALLY INCREASING/ADDING OTHER RISKS. WITH REGARD TO THE HANDLE BREAKING: PREVIOUS INVESTIGATIONS HAVE FOUND THAT DESIGN CHANGE WAS IMPLEMENTED FOR THIS PRODUCT ((B)(4)) TO PREVENT THE ANTI-ROTATION PIN FROM LOADING THE PLASTIC HANDLE TO MINIMISE FURTHER FAILURES OF THE HANDLE CRACKING. (B)(4) WAS CREATED TO INVESTIGATE THE USE OF (B)(4) IN INSTRUMENTS AND CONCLUDED THAT THE DATA SHOWED NO SYSTEMATIC FAILURES OF EXTRUDED (B)(4) FOR USE IN INSTRUMENTS. FOLLOWING THE DRA A HHE WAS COMPLETED ((B)(4)) AND CONCLUDED THAT THE RISK IS MEDIUM AND THAT NO FURTHER ACTION IS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE HANDLE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601886 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 PC30410001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other