BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4376211 · Received December 31, 2014

    Report

    Report Number
    2520274-2014-15707
    Event Type
    Injury
    Date Received
    December 31, 2014
    Report Date
    December 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK110592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 3 UNKNOWN SCREWS OF 9 THAT WERE IMPLANTED. LISTED BELOW ARE THEIR QUANTITIES, PART NUMBERS, LOT NUMBERS, AND DESCRIPTIONS: 1 X 09.223.060S 2753947 ¿ 5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/60MM-STERILE, K110592, HWC, SCREW, FIXATION, BONE. 4 X 09.223.032S 2795770 ¿ 5.0MM COCR DYNAMIC LOCKING 5.0MM COCR DYNAMIC LOCKING, K110592, HWC, SCREW, FIXATION, BONE. 1 X 09.223.055S 2752922 ¿ 5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/55MM-STERILE, K110592, HWC, SCREW, FIXATION, BONE. 1 X 09.223.065S 2752924 ¿ 5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/65MM-STERILE, K110592, HWC, SCREW, FIXATION, BONE. 1 X 09.223.044S 2763702 ¿ 5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/44MM-STERILE, K110592, HWC, SCREW, FIXATION, BONE. 1 X 09.223.075S 2752926 ¿ 5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/75MM-STERILE, K110592, HWC, SCREW, FIXATION, BONE. THE EXACT EXPLANT DATE OF THE IMPACTED SCREWS IS UNKNOWN. DEVICE EXPECTED TO BE RETURNED, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURING SITE. THE LOT NUMBER(S) PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. DEVICE 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGEON SENT AN E-MAIL TO OUR PRODUCT MANAGER ON (B)(6) 2014 WITH AN ATTACHED PRESENTATION THAT INCLUDED X-RAYS OF THREE BROKEN DYNAMIC LOCKING SCREWS AND THE ASSOCIATED PART NUMBERS. THE PRESENTATION INDICATED THAT NINE DYNAMIC LOCKING SCREWS WERE IMPLANTED, BUT IT DID NOT IDENTIFY WHICH OF THOSE NINE SCREWS WERE BROKEN. THEREFORE, THIS REPORT IS FOR 3 UNKNOWN SCREWS. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861800 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention