BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/RT

    MDR report key: 3020357 · Received March 25, 2013

    Report

    Report Number
    3003506883-2013-00114
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RAW MATERIAL WIDTH FEATURE FAILED TO MEET SPECIFICATION REQUIREMENTS DUE TO UNDERSIZED CONDITION. NCR US1045021 WAS DISPOSITIONED AS USE AS IS FOR ITEM 1. THIS NON-CONFORMANCE WILL NOT ADVERSELY AFFECT THE OVERALL PART QUALITY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE APPEARS TO BE IN WORKING ORDER. THE CONNECTION SCREW IS ALSO INCLUDED WITH THE GUIDE BLOCK. THE PART NUMBER AND LOT NUMBER ETCH ARE LEGIBLE. DO NOT IMPLANT IS ALSO IS ALSO VISIBLE IN BOLD FONT ON THE TOP SURFACE OF THE PART. ALTHOUGH THIS RISK IS ADEQUATELY ADDRESSED IN THE RISK ANALYSIS AND THE PART IS CLEARLY ETCHED DO NOT IMPLANT, THE SURGICAL TECHNIQUE OUTLINED IN THE U.S. VERSION OF THE TECHNIQUE GUIDE HAS NO REFERENCE TO REMOVING THE GUIDE BLOCK. CONSIDERING THE TECHNIQUE GUIDE IS REFERENCED AS A REDUCTION MEASURE IN THE RISK ANALYSIS, THIS OMISSION NEEDS TO BE ADDRESSED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL HUMERAL IMPLANT SURGERY ON (B)(6) 2013 THE SURGEON LEFT THE GUIDE BLOCK TO THE 3.5MM LCP PERIARTICULAR PROXIMAL RIGHT HUMERUS PLATE IN THE PATIENT. REPORTEDLY THE GUIDE BLOCK WAS LEFT ON THE PROXIMAL PART OF THE PLATE AT THE FIRST SCREW POSITION. AN X-RAY THE DAY AFTER THE SURGERY SHOWED THE GUIDE BLOCK. THE GUIDE BLOCK WAS REMOVED ON (B)(6) 2013. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121728 INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/RT KTW SYNTHES ELMIRA 6555236

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention