BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3925339 · Received July 10, 2014

    Report

    Report Number
    1719045-2014-10303
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PK962913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: ORCHID UNIQUE MANUFACTURED THE 2.5MM DRILL BIT/QC/GOLD/110MM. THE SUPPLIER¿S CERTIFICATE OF INDICATES THE PARTS WERE MANUFACTURED TO AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET. NO NON-CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP PROSTHETIC IMPLANTED AND DURING THE PERIPROSTHETIC FEMUR FRACTURE PROCEDURE, THE DRILL BIT BROKE AS IT HIT THE TOTAL HIP PROSTHETIC. THE BROKEN PORTION OF THE DRILL BIT COULD NOT BE LOCATED VIA X-RAY AND WAS BELIEVED TO HAVE BEEN DISSOLVED AS IT STRUCK THE TOTAL KNEE PROSTHETICS. THERE WAS LESS THAN A ONE MINUTE DELAY WHILE THE SURGEON SWITCHED DRILL BITS TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT STATUS/OUTCOME IS REPORTED AS FINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403628 2.5MM DRILL BIT/QC/GOLD/110MM BIT, DRILL HTW SYNTHES MONUMENT U197828

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention