BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 BALL HEX DRIVER FOR INSERTER HANDLE

    MDR report key: 6967980 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09024
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED HEX DRIVER IS ALSO IN GOOD OVERALL CONDITION. THE HEX TIP HAS FRACTURED FROM THE REMAINDER OF THE INSTRUMENT. THE HEX TIP WAS NOT RETURNED. A BLUE DISCOLORATION WAS OBSERVED ON THE HANDLE. MINIMAL SURFACE DAMAGE WAS OBSERVED, ONLY A FEW SCUFFS AND IMPACT MARKS WERE FOUND. THE AVERAGE HARDNESS OF THE HEX DRIVER WAS MEASURED AND FOUND TO BE WITHIN THE PRINT SPECIFICATIONS. THE DEVICE WAS SENT TO SEM FOR FRACTURE ANALYSIS AND IT WAS IDENTIFIED THE BALL HAS FRACTURED OFF PERPENDICULAR TO THE MAIN AXIS OF THE SHAFT. THE FRACTURE SURFACE SHOWS A MOSTLY FLAT SURFACE WITH A FEW LIGHT ARTIFACTS IN A CIRCULAR PATTERN, CONSISTENT WITH A ROTATIONAL/TORSIONAL SHEAR FRACTURE THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 010000666, G7 PPS LTD ACET SHELL 58G, 3976980. 110003451, G7 STR MODULAR SHELL INSERTER, 970150. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09022, 0001825034 - 2017 - 09023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE CUP WOULD NOT UNLOCK, AND THE HANDLE WOULD NOT DETACH CAUSING THE BALL HEX DRIVER TO FRACTURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE CUP WOULD NOT UNLOCK, AND THE HANDLE WOULD NOT DETACH CAUSING THE BALL HEX DRIVER TO FRACTURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748710 G7 BALL HEX DRIVER FOR INSERTER HANDLE INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A 486661

    Patients

    Seq Age Sex Outcome Treatment
    1