BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 3131900 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02411
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL PRODUCT CODE(S) FOR THIS REPORT INCLUDE: (B)(4). (B)(6). THE MICROSCOPIC VIEW OF THE BROKEN SURFACES DOES NOT SHOW AND ANOMALIES OF THE MATERIALS STRUCTURE, WHICH INDICATES MATERIAL CONFORMITY. THE BREAKAGE IS POSSIBLY INDICATIVE OF A MECHANICAL OVERLOADING SITUATION DURING USAGE. IT IS ALSO POSSIBLE THE DRILL BIT WAS EXPOSED TO EXTENDED LATERAL STRESS OR MADE CONTACT WITH OTHER METALLIC PARTS. PRODUCT AND MATERIAL RELATED CONDITIONS WERE NOT FOUND. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    WHILE INTRA-OPERATIVELY PERFORMING DRILLING PRIOR TO INSERTING THE IMPLANT, SMALL DISTAL TIP OF THE DRILL BROKE OFF AND WAS LEFT IN THE PATIENT WRIST. THE BROKEN PIECE WAS IRRETRIEVABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235251 2.0MM CANNULATED DRILL BIT/QC 150MM HWE SYNTHES GMBH F-10556

    Patients

    Seq Age Sex Outcome Treatment
    1