BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARROW SCREW REMOVAL PLIERS

    MDR report key: 2962855 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-10206
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT EVALUATION REVEALED THAT ONE ARM OF THE PLIERS IS BROKEN OFF. THE BROKEN FRAGMENT WAS NOT SENT BACK FOR INVESTIGATION. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE AND AS THE BROKEN FRAGMENT WAS NOT SEND BACK. THEREFORE THIS COMPLAINT IS 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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL PLIERS WERE BROKEN. IT IS NOT KNOWN HOW OR WHEN THE PLIERS GOT BROKEN.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66066 NARROW SCREW REMOVAL PLIERS HTC SYNTHES GMBH 3808324

    Patients

    Seq Age Sex Outcome Treatment
    1