BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG

    MDR report key: 3955519 · Received July 24, 2014

    Report

    Report Number
    1000562954-2014-10140
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK120070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; RECEIVED ONE PLATE BROKEN IN THE MIDDLE (HOLE 1 LEVEL). PART RETURNED NOT IN THE ORIGINAL PACKAGING. NO VISUAL DEFECT RELATING TO THE MANUFACTURING PROCESS. THE PLATE HAS BEEN REINSPECTED FOR THE FEATURES PERTINENT TO THE CLAIMED ISSUE. ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION WITH EXCEPTION OF THE HOLES THREE AND FOUR WHICH ARE DAMAGED (POST PRODUCTION). ALL THE HOLES ARE MANUFACTURED WITH THE SAME PARAMETERS AND TOOLS THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE COMPLAINED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DISTAL HUMERUS PLATE BROKE MIDSHAFT AT THE LOCKING HOLE. IT CANNOT BE DETERMINED IF THERE WERE ANY MATERIAL DEFECTS BASED ON OUR INSPECTIONS/TESTING. THE REASON FOR THE DAMAGE TO THE PLATE COULD NOT BE DETERMINED WITH ACCURACY. THE VA-LCP CURVED CONDYLAR PLATE IN QUESTION HAS BECOME FATIGUED DUE TO CYCLIC LOADING. THE MACROSCOPIC STRIATIONS AS WELL AS THE DISCERNABLE FINE FATIGUE LINES AND SECONDARY CRACKS ON THE REMAINING ORIGINAL FRACTURE FACE ARE A SIGN OF A FATIGUE CRACK UNDER CYCLIC OVERLOAD. THE FRACTURE BEHAVIOR IS DUE TO MISSING MACROSCOPIC REST LINES AND RESIDUAL FRACTURE UNREPRODUCIBLE. THE CHARACTER OF THE FRACTURE FACE IN TERMS OF TOPOGRAPHY AND THE EXISTENCE OF SOME MACROSCOPIC SECONDARY CRACKS, INDICATE THAT THE PLATE WAS EXPOSED TO A HIGH STRESS LEVEL WHICH CAUSED THE FAILURE OF THE IMPLANT. THE CAUSE OF FRACTURE CANNOT BE DETERMINED DEFINITELY. 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)(6). EVENT DATE: UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT A REVISION SURGERY OCCURRED DUE TO A BROKEN LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL HUMERUS PLATE. ON (B)(6) 2014, THE SURGEON PERFORMED AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT DISTAL HUMERUS USING AN LCP MEDIAL DISTAL PLATE AND A MEDIAL LATERAL PLATE. ON AN UNKNOWN DATE, DURING A ROUTINE FOLLOW-UP, THE SURGEON CONFIRMED THAT THE LCP MEDIAL DISTAL HUMERUS PLATE WAS BROKEN MID-SHAFT (IN THE MIDDLE) AT THE LOCKING HOLE. THERE WAS NO SCREW IN THE HOLE WHERE THE PLATE BROKE. THE MEDIAL LATERAL PLATE REMAINED INTACT. THE SURGEON EXPLANTED THE BROKEN PLATE, THREE UNKNOWN PROXIMAL SCREWS AND FOUR UNKNOWN DISTAL SCREWS. ALL DEVICES WERE EXPLANTED SUCCESSFULLY AND NO FRAGMENTS WERE REPORTED. THE SURGEON PERFORMED A REVISION OPEN REDUCTION INTERNAL FIXATION PROCEDURE AND IMPLANTED A NEW PLATE AND SCREWS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER PATIENT HARM WAS REPORTED AND NO TIME DELAY WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433869 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 7963872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention