BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM/3.5MM TI VA-LCP POSTLAT DHP 3H/LT/75MM-SHORT-STER

    MDR report key: 7823342 · Received August 28, 2018

    Report

    Report Number
    8030965-2018-56027
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819506718
    PMA / PMN Number
    K120717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: HWC. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART: 04.117.303S; LOT: L800075; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: APRIL 10, 2018; EXPIRY DATE: APRIL 01, 2028 THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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: DURING A SURGERY ON (B)(6) 2018, TWO VARIABLE ANGLE (VA) LOCKING SCREWS COULD NOT BE LOCKED ON VA-LOCKING COMPRESSION PLATE (LCP) DISTAL HUMERUS PLATE (DHP). DRILLING WAS DONE THOROUGH A UNIVERSAL DRILL GUIDE INSTEAD OF A VA LOCKING GUIDE SINCE THE VA LOCKING GUIDE FELL ON THE FLOOR. DUE TO THIS SITUATION, THE ANGLE OF DRILLING WAS NOT PROPER, CAUSING THE LOCKING MECHANISM ON THE PLATE TO BE BROKEN. THE SURGERY WAS COMPLETED WITH A 30-MINUTEDELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: DRILL BIT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), UNIVERSAL DRILL GUIDE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.7MM/3.5MM TITANIUM (TI) VA-LCP POSTLATERAL DHP 3-HOLE/LEFT/75MM-SHORT-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662909 2.7MM/3.5MM TI VA-LCP POSTLAT DHP 3H/LT/75MM-SHORT-STER PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L800075 07611819506718

    Patients

    Seq Age Sex Outcome Treatment
    1