BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS

    MDR report key: 3032208 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-10683
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    August 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. THE MANUFACTURING EVALUATION SHOWED NO VISIBLE DAMAGES. OUR INVESTIGATION HAS SHOWN THAT THE CHUCK JAWS ARE DEFECTIVE AND WORN OUT. THE MANUFACTURING RECORDS SHOW THAT THE DEVICE MET THE SPECIFICATIONS WHEN IT LEFT OUR FACILITIES. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID 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 (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE AND REPAIR THAT THEY WERE NOTIFIED THAT A DRILL/BURR ATTACHMENT, ORDERED BY PRODUCT DEVELOPMENT, WAS TAKEN INTO A PROCEDURE AT (B)(6), AND DURING THE PROCEDURE THE ATTACHMENT (WHICH HAS A FRICTION GRIP) WOULD NOT HOLD THE SHAFTS OF THE DRILL BITS. WHEN THE SURGEON ATTEMPTED TO USE THE ATTACHMENT IT WOULD LOOSEN AND SPIN AROUND BUT WOULD NOT TURN THE DRILL BIT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136075 DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS HWE SYNTHES GMBH 1409

    Patients

    Seq Age Sex Outcome Treatment
    1