BEUDAMED
    FDA Adverse Event Other Summary report: N

    TI SCR THDED HD 2.7X18 MM8

    MDR report key: 4945108 · Received July 24, 2015

    Report

    Report Number
    9613350-2015-00833
    Event Type
    Other
    Date Received
    July 24, 2015
    Date of Event
    April 11, 2015
    Report Date
    July 13, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. THE LOT NUMBER WAS RECEIVED. THE DHR REVIEW WILL BE PERFORMED DURING INVESTIGATION. 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 ASSESMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    DHR REVIEW: DHR RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. TREND ANALYSIS: NO TREND IDENTIFIED. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT WAS REPORTED TO US. THE PRODUCT COMPATIBILITY CHECK IS NOT RELEVANT FOR ONE PRODUCT ONLY. REVIEW OF INCOMING INFORMATION: IT WAS REPORTED THAT TWO SCREWS OF THE SAME LOT BROKE WHEN THE SURGEON WAS FINISHING THE PLACEMENT. THE REMAINDER THAT WAS PLACED HAD NO PROBLEM(DIFFERENT LOT). THE SCREWS REMAINED IN THE PATIENT AND THE HEADS WILL BE RETURNED. NO X-RAYS OR OTHER DOCUMENTS WERE AVAILABLE FOR INVESTIGATION. DEVICES ANALYSIS: DEVICE ANALYSIS COULD NOT BE PERFORMED AS DEVICES WERE NOT AVAILABLE. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: HEX STRIPPING RESULTING IN DAMAGED SCREWS DUE TO INADEQUATE INTERFACE IMPLANT/ INSTRUMENT. POSSIBLE AS IT IS NOT KNOWN WHICH INSTRUMENT WAS USED AND THE PROCEDURE WAS NOT EXPLAINED, THIS POINT COULD NOT BE EXCLUDED. DEFECT OF MEDICAL DEVICE DUE TO INSTRUMENTS (NONFITTING) DUE TO WRONG SURGICAL TECHNIQUE PROCEDURE. POSSIBLE AS WE HAD NO INFORMATION ABOUT THE SURGICAL PROCEDURE WE COULD NOT EXCLUDE THIS POINT. DAMAGE OF IMPLANT DURING SURGERY DUE TO USE OF INADEQUATE INSTRUMENT. POSSIBLE AS IT WAS NOT KNOWN WHICH INSTRUMENT WAS USED, THIS POINT COULD NOT BE EXCLUDED. OVER STRESSING OF THE IMPLANT DUE TO OFF LABEL USE. POSSIBLE AS IT COULD BE THAT THE SCREWS WERE OVER STRESSED DURING SURGERY AND THEREFORE FINALLY BROKE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOW TI SCR THDED HD 2.7X18 MM 8 WERE IMPLANTED ON (B)(6) 2015 (BOTH SCREWS WITH THE SAME LOT NUMBER). THE SCREWS BROKE WHEN THE SURGEON WAS FINISHING THE PLACEMENT. THE REMAINDER THAT WAS PLACED HAD NO PROBLEM. SCREWS REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481943 TI SCR THDED HD 2.7X18 MM8 NORMED TITANIUM OSTEOTOMY PLATING SYST HRS NORMED MEDIZIN-TECHNIK GMBH NA 14691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other