BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKING SCREW Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3243141 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04434
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE HEADS OF THE SCREWS BROKE AWAY AND THE SHAFT THREAD SHOWS SHAVED OFF MATERIAL. IT IS INDICATIVE THAT THE BREAKAGE OCCURRED THROUGH APPLYING TOO MUCH FORCE BY INSERTION INTO THE PLATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH A PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE FOR A DISTAL RADIUS FRACTURE. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 FOR REMOVAL OF A PLATE AND SCREWS. THE REASON FOR REMOVAL IS UNKNOWN. WHILE REMOVING THE VA-TCP PLATE, THE SURGEON TRIED TO ROTATE TWO VA SCREWS IN THE DISTAL ULNAR HOLES. REPORTEDLY, THE SURGEON DID NOT FEEL ANY RESISTANCE AND THE HEAD PARTS WERE REMOVED ONLY. AS THERE WAS NO SOUND OR RESISTANCE DURING THE PROCEDURE, THE SCREWS MAY HAVE ALREADY BEEN BROKEN. THE RESIDUAL SHAFT PARTS WERE REMOVED WITH FORCEPS, AND THERE WAS NO EVIDENCE OF RESIDUE IN THE PATIENTS BODY. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342373 VA LOCKING SCREW Ø2.4 SELF-TAP L18 TAN HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention