BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIPER

    MDR report key: 5083949 · Received September 17, 2015

    Report

    Report Number
    9680938-2015-10091
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Report Date
    September 4, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    KTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: PART NO: 324.06, SERIAL/LOT NO: (B)(4): NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 27 MARCH 1997. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE SET SCREW WAS MISSING. THE REPAIR TECHNICIAN REPORTED MISSING PARTS AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: SET SCREW. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. (B)(4).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

    IT WAS REPORTED THE DEVICE HAS A MISSING SET SCREW. THIS OCCURRED DURING TESTING, NO CASE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617329 CALIPER CALIPER FOR CLINICAL USE KTZ SYNTHES TUTTLINGEN XA7GA08

    Patients

    Seq Age Sex Outcome Treatment
    1