BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    MDR report key: 3322148 · Received September 3, 2013

    Report

    Report Number
    1719045-2013-01918
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Report Date
    August 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ACTUAL EVENT DATE NOT KNOWN. INITIAL REPORTER: TELEPHONE NUMBER: UNKNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THERE WERE NO MRRS, NCRS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT PART 03.503.480 THE DRILL IS OUTSIDE THE TOLERANCE ZONE, IT DOES NOT FIT THROUGH THE DRILL SLEEVE. DRILL 03.503.481 IS STIFF BUT FITS THROUGH THE DRILL SLEEVE. THE BINDING IS DUE TO A DEFORMATION AT THE TIP OF THE DRILL SLEEVE. THE CAUSE OF THE TOO LARGE SHAFT DIAMETER OF 03.503.480 IS INITIALLY UNKNOWN, IT COULD BE INDICATIVE OF AN ERROR FROM THE PRODUCTION. THE DEFORMATION OF THE DRILL SLEEVE IS DUE TO THE APPLICATION. (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. PREVIOUS REPORTS REPORTED DEVICE RECEIPT AND EVALUATION BY THE MANUFACTURER IN ERROR; CORRECTED IN THIS REPORT. INITIAL REPORT REPORTED HTW AND HWE IN ERROR; CORRECTED TO DZI IN THIS REPORT. INITIAL REPORT REPORTED EXEMPT IN ERROR; CORRECTED TO K043310 IN THIS REPORT. INITIAL REPORT INDICATED PRODUCT WAS RECEIVED ON (B)(4) 2013 IN ERROR; CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILLS DO NOT GO THROUGH THE DRILL SLEEVE. NO PRODUCT WAS RECEIVED FOR INVESTIGATION AND NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435983 DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0 DZI SYNTHES MONUMENT U141920

    Patients

    Seq Age Sex Outcome Treatment
    1