BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 5398271 · Received January 29, 2016

    Report

    Report Number
    2520274-2016-10541
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT WAS CRUSHED (BROKE) DURING SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58160 2.0MM CANNULATED DRILL BIT/QC 150MM INSTR, SURGICAL, ORTHOPEDIC, AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1