BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP WRIST FUSION STRAIGHT PLATE

    MDR report key: 3072246 · Received April 23, 2013

    Report

    Report Number
    3003506883-2013-00194
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K042355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE RECEIVED FOR EVALUATION THE 9-HOLE STAINLESS STEEL WRIST FUSION PLATE IS DESIGNED TO BE MANUFACTURED OF IMPLANT QUALITY (B)(4) STAINLESS STEEL, (B)(4). THE HOLES AND HOLE LOCATIONS ARE DIMENSIONED APPROPRIATELY FOR THE ASSOCIATED INDICATIONS, AND ARE STANDARD 3.5MM AND 2.7MM SYNTHES COMBI HOLES. THE PLATE IS ALSO DESIGNED TO BE ADEQUATELY THICK FOR THE ASSOCIATED INDICATIONS, AND THE ELECTROPOLISH FINISH IS PER SYNTHES STANDARD. THE PACKAGING, LABELING, AND STERILIZATION ARE PER SYNTHES STANDARDS, AND A TECHNIQUE GUIDE EXISTS TO EXPLAIN PROPER IMPLANTATION OF THE PLATE. ALL THE SCREWS ARE DESIGNED TO BE MANUFACTURED OF IMPLANT QUALITY (B)(4) STAINLESS STEEL, (B)(4). THEY ARE DESIGNED OF THE CORRECT DIAMETER - 2.7MM AND 3.5MM SCREWS - AND THE HEADS OF THE SCREWS ARE STANDARD 3.5MM AND 2.7MM SYNTHES LOCKING THREADS. THE HEAD OF THE CORTEX SCREW IS APPROPRIATELY DIMENSIONED TO FIT IN THE NON-LOCKING PORTION OF THE COMBI HOLE. THE PACKAGING, LABELING, AND STERILIZATION ARE PER SYNTHES STANDARDS, AND A TECHNIQUE GUIDE EXISTS TO EXPLAIN PROPER IMPLANTATION OF THE SCREWS. NO OTHER DESIGN FACTOR COULD HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LCP WRIST FUSION STRAIGHT PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED A NON-UNION. REPORTEDLY, THE PATIENT WAS NOT COMPLAINING OF PAIN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 AND THE PATIENT UNDERWENT A REVISION OF THE RIGHT WRIST FUSION. THE SURGEON REMOVED THE PLATE AND SCREWS. IT WAS REPORTED TWO 2.7MM LOCKING SCREWS HAD THE HEADS BROKEN OFF AND THE REMAINING PART OF THE TWO SCREWS WERE LEFT IN THE PATIENT (POSSIBLY 14 TO 16 MM) IN THE 3RD METACARPAL. PATIENT WAS REVISED WITH AN 8 HOLE, 3.5 LOCKING PLATE AND 8 SCREWS (4 LOCKING SCREWS AND 4 CORTICAL SCREWS). REPORTEDLY THE PROCEDURE WAS COMPLETED AS PLANNED. THIS IS 1 OF 8 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173717 LCP WRIST FUSION STRAIGHT PLATE HRS SYNTHES ELMIRA 6764779

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention