BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPIC SHOULDER GUIDE SYSTEM

    MDR report key: 238 · Received February 10, 1992

    Report

    Report Number
    238
    Event Type
    Injury
    Date Received
    February 10, 1992
    Date of Event
    January 21, 1992
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPY, SURGEON WAS INSERTING PIN INTO SHOULDER AS A GUIDE WITH THE STRYKER DRILL. DURING PIN INSERTION THE GUIDE PIN BROKE OFF. ATTEMPTS WERE MADE TO REMOVE THE BROKEN PIN BUT THESE ATTEMPTS WERE UNSUCCESSFUL. PT. WAS SENT TO X-RAY TO HAVE PIN LOCALIZED WITH FLUOROSCOPE. PT. WAS RETURNED TO SURGERY THE SAME DAY FOR REMOVAL OF RETAINED PINDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPIC SHOULDER GUIDE SYSTEM SHOULDER PINS HTY ACUFEX MICROSURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention