BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT

    MDR report key: 8358247 · Received February 21, 2019

    Report

    Report Number
    8030965-2019-61219
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    January 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819287907
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE RETURNED LOCKING COMPRESSION PLATE WAS FORWARDED TO THE MANUFACTURING SIDE FOR EVALUATION. THE STATEMENT BELOW IS A SUMMARY OF THEIR INVESTIGATION. THE PLATE IN QUESTION IS BROKEN AT THE HOLE C AND G (COUNTED FROM THE RIGHT TO THE LEFT SIDE). THE COMPLAINT PART HAS TRACES OF USE SUCH AS SEVERAL SCRATCHES ON THE SURFACE. FURTHERMORE, AROUND THE BREAKAGE POINT THERE ARE SEVERAL ABRASIONS AND DAMAGES ON THE SURFACE WITHIN THE HOLES. THE INITIAL AND THE FINAL LOT SIZE WAS 12 PARTS. BESIDES, DURING THE MANUFACTURING RECORD EVALUATION FOR THE LOT NUMBER L429162 NO NON-CONFORMANCES, ABNORMALITIES NOR DEVIATIONS WERE IDENTIFIED WHICH COULD LEAD TO THE COMPLAINT FAILURE. ALL DIMENSIONS OF THE PLATE RECEIVED WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION SUCH AS THE THICKNESS IN THE AREA FROM THE HOLES C AND G WERE MEASURED AND HAVE FULFILLED THEIR SPECIFICATIONS. NOTEWORTHY, THE FEATURES OF THREAD ZERO-POINT HOLES C AND G COULD NOT BE MEASURED DUE TO THE COMPLAINT CONDITION (BROKEN PLATE). BESIDES, DURING THE MANUFACTURING PROCESS THE LOT RELATED TO THIS COMPLAINT WAS INSPECTED REGARDING TO ITS DIMENSIONAL FEATURES SUCH AS BALL HEIGHT, THICKNESS AND THREAD ZERO POINT THROUGH THE INSPECTION AND THE WHOLE LOT HAS PASSED ITS SPECIFICATIONS. THEREFORE, THIS PLATE WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND A MANUFACTURING ISSUE HAS BEEN EXCLUDED. THE RECEIVED CONDITION OF THE DEVICE AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE PLATE IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW, THIS COMPLAINT IS RATED AS NOT VALID SINCE NO DEVIATIONS WERE FOUND IN THE MANUFACTURING DOCUMENTATION REVIEWED, AS WELL AS ALL MEASUREMENTS PERFORMED DURING THIS INVESTIGATION ARE ACCORDING TO SPECIFICATIONS. SINCE NO MANUFACTURING ISSUE WAS DETECTED, THEREFORE, NO FURTHER ACTIONS HAVE BEEN TAKEN. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED DEVICE HISTORY LOT, PART: 422.254, LOT: L429162, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 30. MAY 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    (B)(4). THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANT PROCEDURE ON (B)(6) 2018. ON (B)(6) 2019, A PATIENT UNDERWENT REVISION SURGERY DUE TO A BREAKAGE OF TITANIUM LOCKING COMPRESSION PLATE (LCP) DISTAL RIGHT FEMUR PLATE AND FRAGMENTS WERE GENERATED. DURING THE REVISION SURGERY, PLATE WAS EXPLANTED AND IT WAS REPLACED WITH ANOTHER LOCKING COMPRESSION PLATE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREWS (PART 413.380, LOT L939971, QUANTITY 2); LOCKING SCREW (PART 413.380, LOT 1L61065, QUANTITY 1); LOCKING SCREWS (PART 413.375, LOT L925787, QUANTITY 1); LOCKING SCREWS (PART 413.375, LOT 2L24055, QUANTITY 1); LOCKING SCREW (PART 413.370, LOT# 2L36592, QUANTITY 1); LOCKING SCREW (PART 413.370, LOT 1L96034, QUANTITY 1); LOCKING SCREW (PART 413.334, LOT 1L43814, QUANTITY 1); LOCKING SCREW (PART 413.334, LOT 1L49422, QUANTITY 1); LOCKING SCREW (PART 413.334, LOT 8138888, QUANTITY 1); LOCKING SCREW (PART 413.334, LOT 8022752, QUANTITY 1). THIS REPORT IS FOR ONE (1) LCP PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152400 TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L429162 07611819287907

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention