BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS

    MDR report key: 3082675 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11119
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT SOME SMALL PARTS OF THE THREAD FLANKS ARE BROKEN OFF. BASED ON THE EVALUATION PERFORMED AND ON THE FACT THAT THE DAMAGED PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION OF THE TIP FEATURES IMPOSSIBLE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HARDWARE REMOVAL, THE TIPS OF TWO CONICAL EXTRACTION SCREWS BROKE OFF INTO THE HEAD OF THE SCREW. ALL HARDWARE WAS REPORTEDLY REMOVED, THE BROKEN TIPS WERE RETRIEVED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183900 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS HWB SYNTHES GMBH 2645643

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR