BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø2.4 SELF-TAP L20 SST

    MDR report key: 3122696 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02821
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 22, 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 IS USED FOR TREATMENT, NOT DIAGNOSIS THE MEASURABLE DIMENSIONS OF THE RETURNED LOCKING SCREW COULD NOT BE CHECKED FOR ITS SPECIFICATION AS THERE WAS NO LOT NUMBER PROVIDED. UNFORTUNATELY ALSO THE SAME APPLIES FOR THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPER. IT IS POSSIBLE THAT TOO HIGH MECHANICAL FORCE DURING INSERTION HAS LED TO THE BREAKAGE OF THE SCREW HEAD. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HRS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH RIGHT DISTAL RADIUS FRACTURE WAS TREATED WITH CORRECTIVE OSTEOTOMY ON (B)(6) 2013. THE SURGEON DISSECTED BY PLANES AND PERFORMED OSTEOTOMY WITH SAW BLADE. THE PLATE WAS PLACED AND FIXED DISTALLY WITH LOCKING SCREWS AND THE PLATE WAS FIXED TEMPORARILY INTO THE DIAPHYSIS WITH SPANISH CLAMP. THE CORTICAL SCREWS WERE PLACED. A RADIOGRAPHIC IMAGE WAS TAKEN AND WAS SATISFACTORY. THE SURGEON THEN BEGAN TO PLACE THE LOCKING SCREW. REPORTEDLY AT THE MOMENT OF LOCK, A SOUND WAS HEARD AND IT WAS NOTED THAT THE SCREW HEAD REMAINED IN THE SCREWDRIVER AND THE SCREW SHAFT REMAINED INSIDE THE PATIENTS BONE. AFTER SEVERAL ATTEMPTS AND WITH THE HELP OF IMAGE INTENSIFIER, THE SURGEON WAS ABLE TO RECOVER THE SCREW SHAFT. THE SURGEON DECIDED NOT TO PLACE ANOTHER SCREW IN THAT HOLE AND CHANGED THE ORIFICE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224678 LOCKSCR Ø2.4 SELF-TAP L20 SST HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention