BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING DRILL GUIDE FOR EXPANSIONHEAD SCREWS

    MDR report key: 3009191 · Received March 18, 2013

    Report

    Report Number
    3003787298-2013-10049
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    August 26, 2011
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NONCONFORMANCES RELATED TO THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT ONE OF THE TIPS NEXT TO THE BROKEN ONE IS WORN SIGNIFICANTLY AND THE EDGE IS WORN SO THAT IT IS LESS THAN HALF THE ORIGINAL THICKNESS. THE INSTRUMENT ACTUATES AS DESIGNED AND THE INNER SLEEVE IS SLIGHTLY OUT OF ROUND AND SHOWS CONSIDERABLE WEAR ON THE LEADING EDGE. THE PRODUCT DEVELOPMENT EVALUATION DEEMS THIS COMPLAINT INVALID.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. CORRECTED PRODUCT CODE: KWQ, ORIGINALLY REPORTED AS KWO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE INSTRUMENTS WERE DAMAGED IN THE STERILIZATION PROCESS BEFORE SURGERY. A LOCKING DRILL GUIDE HAS A BROKEN PHALANGE ON THE TIP, A DRILL TAP AND SCREW GUIDE HAS A NIPPLE BROKEN OFF AND A COUNTERTORQUE WRENCH IS MISSING TWO PRONGS. THERE WAS NO PATIENT INTERACTION. THIS IS ONE OF THREE REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS ONE OF THREE REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112162 LOCKING DRILL GUIDE FOR EXPANSIONHEAD SCREWS LXH SYNTHES JENNERSVILLE A4FK207

    Patients

    Seq Age Sex Outcome Treatment
    1