BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM

    MDR report key: 3940159 · Received July 17, 2014

    Report

    Report Number
    2520274-2014-12652
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK912932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: ONE SCREW AND ONE SCREW HEAD WERE RECEIVED; BOTH ARE VERY DAMAGED. SWISS TECH MANUFACTURED THE 1MM SCREW, PART NUMBER 400.406, ON UNKNOWN LOT NUMBER. NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. NO MEASUREMENTS OR EVALUATION CAN BE PERFORMED DUE TO DAMAGE. DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED, BUT PER THE EVALUATION, THE CAUSE IS NOT MANUFACTURING RELATED. DEVICE WAS 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

    IT WAS REPORTED THAT A SURGEON WAS PERFORMING SURGERY ON A PATIENT'S INFRAORBITAL RIM USING SCREWS TO REPAIR THE INFRAORBITAL RIM. DURING THE PROCEDURE, 2 OF THE SCREW SHAFTS SHEARED OFF LEVEL WITH THE RIM. IT WAS NOTED THAT THE SCREWS HAD BEEN PRE-DRILLED USING A 0.76 MM DRILL BIT WITH AN 8 MM STOP. THE SHAFTS WERE UNABLE TO BE RETRIEVED BUT THE HEADS WERE SUCCESSFULLY REMOVED; THE SURGEON DID NOT ANTICIPATE A PROBLEM WITH THE PIECES THAT REMAINED. FIXATION WAS ACHIEVED USING ADDITIONAL SCREWS. PATIENT RECOVERED FROM SURGERY. NO POST-OPERATIVE ISSUES WERE REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418630 1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR