BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: HUMERUS

    MDR report key: 13671829 · Received March 4, 2022

    Report

    Report Number
    8030965-2022-01391
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    February 4, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNK - PLATES: HUMERUS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE EXTRA-ARTICULAR HUMERUS SYSTEM, WITH PLATES AND COMPLETE SCREWS, A SAFETY STOP IS MADE WITH THE CONFIDENCE THAT THE MATERIAL IS COMPLETE. WHEN THE PATIENT IS ANESTHETIZED AND DRESSED, THE EQUIPMENT WRAPPERS ARE FINISHED OPENING TO REMOVE WHAT IS NECESSARY FOR THE SURGERY, AND WHEN OPENING THE LID OF THE BOX WHERE THE PLATES AND SCREWS WERE SUPPOSED TO COME, IT IS EVIDENT THAT IT CAME WITH SCREWS AND PLATES. PEDIATRIC PCL OF THE FEMUR, THE SURGEON IS PROMPTLY NOTIFIED, AND THE CENTRAL OFFICE PROCEEDS TO VERIFY THAT IT HAD NOT BEEN EXCHANGED WITH ANOTHER REFERRAL FROM ANOTHER PATIENT, BUT THIS WAS NOT THE CASE. IT WAS THE ONLY REFERRAL THEY RECEIVED THE DAY BEFORE, WHICH IS WHY IT IS CALLED TO PROGRAMMING SO THAT HE WILL VERIFY WITH JYJ, IN THE DELIVERY OF THE MATERIAL THE BOXES WERE EXCHANGED WITH THOSE OF ANOTHER PATIENT, THE PATIENT ALREADY ANESTHETIZED THE ONLY SOLUTION WAS TO WAKE HER UP AND FOR THE DOCTOR TO SPEAK WITH THE FAMILY MEMBER TO RESCHEDULE HER, FOR WHICH IN THE INSTITUTION THEY SPEND THE ADVERSE EVENT REPORT AND COMPLAINT. THIS REPORT IS FOR ONE (1) UNK - PLATES: HUMERUS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980807 UNK - PLATES: HUMERUS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Female UNK - SCREWS: LOCKING