BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS

    MDR report key: 3032217 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-10698
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    August 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    HEALTH 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED IT IS NOT POSSIBLE TO ATTACH A BURR. WE FOUND THAT A BEARING WITHIN THE HOUSING IS DAMAGED AND THAT THEREFORE THE COUPLING SLEEVE DOES NOT LATCHING ANYMORE. THEREFORE IT IS IMPOSSIBLE TO ATTACH A BURR. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. INSUFFICIENT LUBRICATION, HIGH VIBRATIONS OR APPLYING TOO MUCH FORCE DURING USE COULD BE POSSIBLE REASONS. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. (B)(4).

    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 08/09/2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SETTING UP THE BURR ATTACHMENTS FOR THE ELECTRIC PEN DRIVE PRIOR TO A 3RD MOLAR PROCEDURE, THE DOCTOR DISCOVERED THAT THE LOCKING MECHANISM ON THE ATTACHMENT DOES NOT HOLD THE BURR SECURELY. THE ATTACHMENTS WERE NOT USED IN THE PROCEDURE. THERE WAS NO EFFECT ON ANY PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136124 DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS HWE SYNTHES GMBH 1399

    Patients

    Seq Age Sex Outcome Treatment
    1