BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEGREE TARGETING DEVICE

    MDR report key: 2622 · Received March 9, 1993

    Report

    Report Number
    33462-1993-09002
    Event Type
    Injury
    Date Received
    March 9, 1993
    Date of Event
    January 9, 1993
    Report Date
    January 9, 1993
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    HLP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    130 DEGREE GAMMA NAIL IMPLANTED. SURGEON WAS ABLE TO (WITH DIFFICULTY) GET THE PROXIMAL SCREW INSERTED - AS HE TARGETED THE DISTAL HOLE - TARGETING DEVICE CREATED A POSTERIOR POSITIONED HOLE - WAS UNABLE TO DO FREEHAND SCREW PLACEMENT - HOLE ABONDONEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 130 DEGREE TARGETING DEVICE Implant HLP HOWMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention