BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM

    MDR report key: 3895406 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12075
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK000684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEDWATCH REPORT FOR THIS EVENT WAS ORIGINALLY FILED AS A PRODUCT PROBLEM AND ADVERSE EVENT. THE INVESTIGATION OF THE RETURNED DEVICES WAS ABLE TO DETERMINE THE SPECIFIC PART(S ) INVOLVED IN THIS EVENT THAT HAD A PRODUCT PROBLEM. IT WAS DETERMINED NO PRODUCT FAULT OCCURRED WITH THIS PART THEREFORE THIS REPORT IS A CORRECTION TO REFLECT ONLY AN ADVERSE EVENT. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4) 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. DATE UNKNOWN AS THE EVENT IS THE DUE TO A NONUNION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION SURGERY FOR A PATIENT WHO HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT OLECRANON ON (B)(6) 2013. X-RAYS WERE TAKEN POST-OPERATIVELY FROM INITIAL SURGERY ON (B)(6) 2013. THE X-RAYS TAKEN ON AN UNKNOWN DATE PRIOR TO REVISION SHOWED A NON-UNION AND SOME OF THE VARIABLE ANGLE LOCKING SCREWS BACKING OUT OF THE PLATE. DURING THE REVISION SURGERY ON (B)(6) 2014, THE SURGEON NOTICED ONE OF THE SCREWS THAT HE REMOVED HAD A GOUGE WITH A FRAGMENT MISSING. THE SURGEON REMOVED ALL FRAGMENTS. THE PLATE AND AN UNKNOWN NUMBER OF SCREWS WERE REMOVED. THE SURGEON IMPLANTED A DIFFERENT 3.5 LOCKING COMPRESSION PLATE WITH AN UNKNOWN NUMBER OF SCREWS. IT WAS REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THIS REPORT IS FOR THE NON-UNION IT IS UNKNOWN IF THERE WAS AN ISSUE WITH THIS PART NUMBER FOR THE LOCKING SCREW THIS IS REPORT 13 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370129 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention