BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT/QC/100MM

    MDR report key: 3020858 · Received March 26, 2013

    Report

    Report Number
    3003506883-2013-10070
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 (310.19) DRILL BIT WAS RECEIVED IN A PLASTIC POUCH AND A PUNCTURED TIP-GUARD WAS FOUND ON THE FLUTE-END. ONCE THE DRILL BIT AND THE TIP-GUARD WERE SEPARATED, THE DRILL BIT WAS FOUND TO BE BROKEN IN TWO PIECES. THE BREAK-POINT WAS LOCATED APPROXIMATELY 83.00MM FROM THE REAR-END; THIS BREAK-POINT WAS ON THE FLUTED AREA WHICH HAS LESS MATERIAL COMPARED TO THE NON-FLUTED AREA. THE RAW MATERIAL, SHAFT DIAMETER AND THE CORE DIAMETER WERE FOUND TO BE WITHIN THE SPECIFICATION ALLOWED PER THE TOP LEVEL DRAWING, AND EVIDENCE WAS GATHERED REGARDING THE BREAK-POINT AND THE BEND FOUND ON THE DRILL BIT. IT HAS BEEN DETERMINED THAT THE DRILL BIT WAS BROKEN POST-PACKAGING; HOWEVER, IT CANNOT BE DETERMINED HOW IT BROKE POST-PACKAGING. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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 PRODUCT CODE FOR THIS REPORT INCLUDES HSZ. THE 510(K)NUMBER: K962913.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A BRAND NEW DRILL BIT ORDERED LAST WEEK WAS BROKEN WHEN THEY REMOVED IT FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123091 2.0MM DRILL BIT/QC/100MM HTW SYNTHES ELMIRA 6695184

    Patients

    Seq Age Sex Outcome Treatment
    1