BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PLT T-SHP 90° 6-HS HAND-S

    MDR report key: 6278622 · Received January 26, 2017

    Report

    Report Number
    0009613350-2017-00140
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    November 23, 2016
    Report Date
    January 2, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. TWO X-RAYS WERE RECEIVED AND WILL BE REVIEWED WITHIN INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    NO TREND IDENTIFIED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT WAS REPORTED THAT THE PLATE WAS BROKEN APPROX. 3 MONTHS AFTER IMPLANTATION. IT IS MENTIONED THAT DURING THE HEALING PROCESS (UNKNOWN DATE) THE PATIENT ((B)(6)) HIT LIGHTLY A TABLE. REVIEW OF RECEIVED DATA: - TWO UNDATED X-RAY PICTURES WERE SENT. THE PICTURES ARE IN A VERY POOR QUALITY. HOWEVER, THE BREAKAGE OF THE PLATE CAN BE SEEN ON BOTH PICTURES. NO OTHER STATEMENT CAN BE MADE. DEVICES ANALYSIS: - VISUAL EXAMINATION: THE BROKEN PLATE AND 6 SCREWS WERE RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION SHOWS THAT THE PLATE WAS BROKEN INTO TWO PARTS. THE PLATE HAS A GREEN COLOR ANODIZATION (COLOR CODE). THE COLOR CODING HELPS TO APPLY THE CORRECT SCREWS FOR PLATE FIXATION OF THE RESPECTIVE SIZE. ON THE RETURNED PLATE IT CAN BE SEEN THAT THE AREA AROUND THE BREAKAGE IS DISCOLORED SO THE GREEN COLOR CANNOT BE SEEN ANYMORE. IT IS UNKNOWN HOW THIS WAS OCCURRED. THE SCREWS SHOW SMALL DAMAGES ON THE THREAD. NO OTHER RELEVANT DAMAGES OR ABNORMALITIES CAN BE DETECTED. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: - BREAKAGE OF IMPLANT/NON UNION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE (E.G. STRENGTH, STIFFNESS) => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. - BREAKAGE DUE TO CONTOURING OF THE IMPLANT DUE TO MARKS ON THE PLATE DUE TO BENDING INSTRUMENT => POSSIBLE: IT CANNOT BE CONFIRMED THAT THE PLATE WAS NOT BENT. THE HEAD OF THE PLATE SEEMS TO BE BENT. - FRACTURE OF IMPLANT DUE TO CHEMICAL / GALVANIC/ CREVICE CORROSION OF MATERIAL => NOT POSSIBLE: NO CORROSION CAN BE FOUND THE PLATE. - BREAKAGE DUE TO CONTOURING OF THE IMPLANT DUE TO OVER BENDING OF THE PLATE => POSSIBLE: IT CANNOT BE CONFIRMED THAT THE PLATE WAS NOT BENT. THE HEAD OF THE PLATE SEEMS TO BE BENT. - IMPLANT FAILURE DUE TO IMPLANTATION OF A DAMAGED IMPLANT => POSSIBLE: IT IS POSSIBLE THAT A DAMAGED PLATE WAS IMPLANTED. IT IS UNKNOWN HOW THE DEVICE WAS PREPARED PRIOR TO SURGERY. - OVER STRESSING OF THE IMPLANT DUE TO OFF LABEL USE OF IMPLANTS => POSSIBLE: THE PLATE WAS MOST POSSIBLE OVER STRESSED. IT WAS ALSO REPORTED THAT THE PATIENT HIT A TABLE. CONCLUSION SUMMARY: THE PLATE WAS IMPLANTED ON (B)(6) 2016 AND REMOVED ON (B)(6) 2016 DUE TO A BREAKAGE. THE PLATE WAS IN VIVO FOR APPROX. 3 MONTHS. THE VISUAL EXAMINATION OF THE PLATE SHOWED THAT THE PLATE WAS BROKEN INTO TWO PARTS . NO ABNORMALITIES FOR THE SCREWS COULD BE DETECTED. IT WAS ALSO REPORTED THAT AFTER THE SURGERY THE PATIENT HIT LIGHTLY A TABLE WITH HIS HAND (UNKNOWN DATE). DURING THE HEALING PROCESS, THE LOAD CARRYING CAPACITY OF THE BONE IS RESTORED, SHIELDING THE OSTEOSYNTHESIS DEVICES FROM CONTINUED LOADING. THEREFORE, IT IS MOST POSSIBLE THAT THE MINI PLATE WAS BROKEN DUE TO HIGH FORCES APPLIED DURING THE HEALING PROCESS. HOWEVER, AN EXACT ROOT CAUSE FOR THE PLATE BREAKAGE COULD NOT BE DETERMINED. 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 PATIENT WAS IMPLANTED A TI PLATE T-SHP 90 6-HS HAND-S ON (B)(6) 2016 TO TREAT A PHALANGEAL FRACTURE. ON (B)(6) 2016, A CONTROL IMAGE SHOWED A PLATE FRACTURE. A REVISION SURGERY TOOK PLACE ON (B)(6) 2016. IT WAS FURTHER REPORTED BY PATIENT'S PARENTS THAT DURING CONVALESCENCE THE KID ONE TIME ACCIDENTALLY HIT LIGHTLY A TABLE WITH HIS HAND BUT DIDN'T FEEL ANY PAIN OR THAT SOMETHING WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62767 TI PLT T-SHP 90° 6-HS HAND-S NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM HRS ZIMMER GMBH N/A 16262

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R