BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP F/2.0MM RESORBABLE CORTEX SCREW/(SLF-DRLG) 6MM-STERILE

    MDR report key: 3033617 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-10539
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    July 13, 2011
    Report Date
    August 9, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REPORTED A CASE WHERE RESORBABLE SCREWS WOULD NOT GAIN PURCHASE IN THE BONE AFTER TAPPING. SURGEON STATES HE TRIED THE MESH ON ANOTHER PATIENT WITH 2.0 TAPS AND 6MM LONG SCREWS AND HAD THE SAME ISSUE SO HE DID NOT USE THE MESH. NO REPORTED PATIENT HARM. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    (B)(6). THE SCREWS AND MESH USED WERE REMOVED DURING INITIAL SURGERY AS SCREWS WOULD NOT ENGAGE BONE. LOT NUMBERS USED DURING SURGERY INCLUDE 2658895, 2634361, 5886638, 5570213, AND 2403111. SURGEON EXPLAINED HE HAD NO FURTHER INFORMATION ABOUT THE SURGERIES AND PARTS USED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136049 TAP F/2.0MM RESORBABLE CORTEX SCREW/(SLF-DRLG) 6MM-STERILE HWX SYNTHES MONUMENT 5570213

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR