BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR HANDLE

    MDR report key: 4815993 · Received June 3, 2015

    Report

    Report Number
    1719045-2015-10351
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Report Date
    May 12, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY EVALUATION/REVIEW WAS ATTEMPTED ON LOT #3082246, NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 4-FEB-2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. ANOTHER SERVICE & REPAIR EVALUATION WAS PERFORMED: THE CUSTOMER REPORTED THE BLADE SCREWS WERE MISSING. THE REPAIR TECHNICIAN REPORTED MISSING PARTS AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: BLADE SCREW. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON (B)(4) 2015. THE EVALUATION WAS CONFIRMED. 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 · 1

    THE SERVICE AND REPAIR DEPARTMENT REPORTED THAT THE, RETRACTOR HANDLE, SYNTHES EVALUATION EQUIPMENT FAILED INSPECTION: MISSING BLADE SCREWS. NO SURGICAL INFORMATION AVAILABLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359137 RETRACTOR HANDLE RETRACTOR GAD SYNTHES HAGENDORF 3082246

    Patients

    Seq Age Sex Outcome Treatment
    1