BEUDAMED
    FDA Adverse Event Other Summary report: N

    TI SCR THDED HE 2.7X14 MM 8

    MDR report key: 4927767 · Received July 17, 2015

    Report

    Report Number
    9613350-2015-00803
    Event Type
    Other
    Date Received
    July 17, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 18, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IDENTIFIED. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT TYPE WAS REPORTED TO US. THE PRODUCT COMPATIBILITY CHECK IS NOT RELEVANT FOR ONE PRODUCT ONLY. REVIEW OF INCOMING INFORMATION EVENT DESCRIPTION: DURING SURGERY, THE SCREWS SHEARED AT THE AREA OF THE SCREW HEAD. DEVICES ANALYSIS VISUAL EXAMINATION: THE SCREWS SHOW SIGNS OF USAGE ON THE THREADED HEAD. ON ONE SCREW, THERE IS A SHEARED METAL SPAN, WHICH IS STILL CONNECTED TO THE SCREW. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA LINE 3 : HEX / SLOT STRIPPING DURING INSERTION RESULTING IN DAMAGED SCREWS -> DUE TO INADEQUATE INTERFACE IMPLANT/ INSTRUMENT; LINE 26 : DEFECT OF MEDICAL DEVICE DUE TO INSTRUMENTS (NON-FITTING) -> DUE TO WRONG SURGICAL PROCEDURE; LINE 27 : DAMAGE OF THE IMPLANTS / INSTRUMENTS DURING SURGERY -> DUE TO USE OF INADEQUATE INSTRUMENTS DUE TO LACK OF COMPATIBILITY INFORMATION WITH OTHER DEVICES. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: LINE 3: POSSIBLE -> AS ACCORDING MACHING INSTRUMENT WAS NOT RETURNED FOR INVESTIGATION. LINE 26 : POSSIBLE -> AS IT IS NOT KNOWN HOW THE INSTRUMENT WAS USED. LINE 27 : POSSIBLE -> AS IT IS NOT KNOWN HOW THE INSTRUMENT WAS USED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, IT WAS NOT POSSIBLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS TIGHTENING THE SCREWS, THEY CROSS THREADED AND SHEARED AT PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465892 TI SCR THDED HE 2.7X14 MM 8 FOOT BONE PLATE SYSTEM HRS NORMED MEDIZIN-TECHNIK GMBH NA 13597/269D13-79866

    Patients

    Seq Age Sex Outcome Treatment
    1 Other