BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM

    MDR report key: 4213402 · Received October 30, 2014

    Report

    Report Number
    9612488-2014-10482
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDE; HWC. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE PLATE IS BENT AND THERE ARE SCRATCHES ON THE TOP SURFACE VISIBLE. THE SCRATCHES ON THE TOP SURFACE OF THE PLATE CAN BE TRACED BACK TO CABLE MOVEMENT AS THEY ARE LOCATED NEXT TO THE LOCKING HOLES AND ARE ONLY ON ONE SIDE OF THE PLATE. IT CANNOT BE DETERMINED WHY THE PLATE IS BENT. THE PLATE WAS CONTOURED DURING THE INSERTION OR ANY OCCURRENCE DURING THE EXPLANATION CAUSED THE DEFORMATION. ALSO A STRONG IMPACT COULD HAVE CAUSED THE DEFORMATION. THIS WOULD ALSO EXPLAIN THE FORCED RUPTURE OF SOME OF THE CABLES. THERE IS NO ALLEGATION AGAINST THE PLATE. THE INVESTIGATION OF THE CABLES HAS SHOWN THAT THE CABLES COULD NOT RESIST THE APPLIED FORCE WAND FINALLY A MECHANICAL OVERLOAD / FATIGUE FAILURE CAUSED THE BREAKAGE. THERE IS NO INDICATION THAT THE PLATE HAS CONTRIBUTED TO THIS OCCURRENCE. 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

    ADDITIONAL NARRATIVE: 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: THE PATIENT HAS HYPOPHOSPHATAEMIC RICKETS AND WAS ADMITTED WITH A PERIPROSTHETIC FRACTURE OF THE LEFT FEMUR. THIS WAS FIXED USING PLATES, CABLES AND SCREWS. THE PATIENT HAD BEEN TOUCH WEIGHT BEARING; SAT DOWN THEN FELT THE PLATE GIVE WAY. X-RAYS SHOWED THAT SOME OF THE CABLES HAD SNAPPED AND THE FRACTURE WAS NO LONGER REDUCED. THE PATIENT HAS NOW HAD TO UNDERGO REVISION HIP SURGERY ON (B)(6) 2014 FOR A STEM THAT WAS WELL FIXED. IT WAS ALSO REPORTED BY AN INTERNAL REVIEW OF XRAYS BY THE MEDICAL DIRECTOR CONFIRMING THAT; THAT ONE XRAY SHOWS THAT THERE IS A PERIPROSTHETIC FRACTURE THAT WAS TREATED WITH A PLATE, CABLES AND SCREWS. THE SECOND XRAY SHOWS THIS FRACTURE LOST REDUCTION AND AT LEAST 2 OF THE CABLES ARE BROKEN. THERE WERE NO REPORTS IF A SURGICAL DELAY OR PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696130 4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM PLATE,FIXATION,BONE HRS SYNTHES BETTLACH 2647571

    Patients

    Seq Age Sex Outcome Treatment
    1