BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/180MM

    MDR report key: 4620600 · Received March 20, 2015

    Report

    Report Number
    3003506883-2015-10060
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 9, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; GFF, GFA, 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 PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND 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 DURING SURGERY FOR OPEN REDUCTION INTERNAL FIXATION OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ACETABULUM, THE DRILL BIT PART # 310.23, LOT # 7873188 BROKE OFF IN THE PATIENT. IT WAS NOT RETRIEVED, AS IT WAS UNDER THE IMPLANTED PLATE. X-RAYS WERE TAKEN BUT ARE NOT AVAILABLE. NO PATIENT HARM NOTED TO THE PATIENT. NO SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189382 2.5MM DRILL BIT/QC/GOLD/180MM INSTR, SURGICAL, ORTHOPEDIC, AC HWE SYNTHES ELMIRA 7873188

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention