BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM DRILL BIT/MINI QC/80MM

    MDR report key: 3082662 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10919
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. WITHOUT THE ORIGINAL PACKAGE AVAILABLE FOR REVIEW, IT IS IMPOSSIBLE TO DETERMINE THE VALIDITY OF THIS COMPLAINT. THIS COMPLAINT IS DEEMED INDETERMINATE. 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. ADDITIONAL INFORMATION: (B)(4). THE MANUFACTURING EVALUATION WAS COMPLETED ON 07/31/2012. CLARIFICATION: THE 2.4MM DRILL BIT WAS RECEIVED FOR A MANUFACTURING EVALUATION WITHOUT ITS ORIGINAL PACKAGING, AND THE OVERALL PRODUCT CONDITION INDICATES THAT MORE LIKELY THIS DRILL BIT WAS NEVER USED. NO SIGNS OF ANY USE, DAMAGE OR VISUAL NONCONFORMITIES WERE OBSERVED. THE RETURNED PART WAS ETCHED WITH PART NUMBER 317.871 AND LOT NUMBER U134066. WITHOUT THE ORIGINAL PACKAGE AVAILABLE FOR REVIEW, IT IS IMPOSSIBLE TO DETERMINE THE VALIDITY OF THIS COMPLAINT. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE FACILITY WAS PREPARING AND STOCKING SETS, THE FACILITY OPENED A DRILL BIT PACKAGE THAT HAD ONE NUMBER ON THE PACKAGE HOWEVER, THE NUMBER AND TYPE OF DRILL BIT INSIDE THE PACKAGE WAS DIFFERENT. THE CONSULTANT CONFIRMED THAT THE FACILITY NOTED THAT THE PACKAGING WAS BRAND NEW AND INTACT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183781 2.4MM DRILL BIT/MINI QC/80MM HTW SYNTHES MONUMENT U134066

    Patients

    Seq Age Sex Outcome Treatment
    1