BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø1.5 SELF-TAP L10 TAN

    MDR report key: 3001337 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-00533
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQN
    PMA / PMN Number
    K981275
    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. ADDITIONAL PRODUCT CODE: DZL 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MEASURABLE DIMENSION COULD NOT BE CHECKED FOR ITS SPECIFICATION AS THERE IS NO LOT NUMBER PROVIDED. UNFORTUNATELY ALSO THE SAME APPLIES FOR THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPER. THE INVESTIGATION SHOWS NO IRREGULARITIES. THE SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. WE ARE AWARE OF THE FACT THAT THIS IS A DELICATE SCREW; NEVERTHELESS WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN OPEN REDUCTION INTERNAL FIXATION OF TWO METACARPAL FRACTURES PROCEDURE, REPORTEDLY THREE CORTEX SCREWS BROKE DURING INSERTION AND ANOTHER SCREW APPEARED TO BENT WHEN REMOVED FROM THE SCREW CADDY. IT WAS REPORTED THE SURGEON WAS USING MINIMAL TORQUE DURING SCREW INSERTION WITH FINGER TIGHTENING ONLY. THE SURGEON HAD TO REMOVE THE SCREWS DEBRIS AND REPLACE WITH A LONGER 5 HOLE, L PLATE INSTEAD OF THE 4 HOLE PLATE, STRAIGHT PLATE. THE SURGEON REPORTED SATISFACTORY FIXATION AT THE END OF THE PROCEDURE. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105731 CORTSCR Ø1.5 SELF-TAP L10 TAN MQN SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention