BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT HOHMANN RETRACTOR W/35 L275

    MDR report key: 3130948 · Received May 24, 2013

    Report

    Report Number
    1719045-2013-01485
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    February 22, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ADDITIONAL EVALUATION REVEALED THAT BOTH TIPS WERE BADLY DAMAGED DUE TO MECHANICAL MISHANDLING WHILE IN USE. AT ONE TIP, A SMALL FRAGMENT WAS BROKEN OFF. TOO GREAT A MECHANICAL FORCE WAS APPLIED ONTO THE THIN TIP BLADES OF THE INSTRUMENTS. WE HAVE TO ASSUME THAT THE TIPS CAME INTO STRONG CONTACT WITH A METALLIC PART DURING SURGERY AND WERE DAMAGED AS A RESULT. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THE TIPS ARE BROKEN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232250 RADIOLUCENT HOHMANN RETRACTOR W/35 L275 GAD SYNTHES MONUMENT 721658

    Patients

    Seq Age Sex Outcome Treatment
    1