BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS SELF-CENTER SOFTLO

    MDR report key: 3183603 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03898
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    April 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THE MANUFACTURING DOCUMENTS SHOW CONFORMITY TO SPECIFICATION. THE INVESTIGATION OF THE FORCEPS SHOWS THAT ONE PART OF THE TIP IS BROKEN OFF. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATED MATERIAL CONFORMITY. NO FURTHER DAMAGES ARE VISIBLE. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FORCEPS BROKE DURING SURGERY. ACCORDING TO THE SURGEON, EXCEPTIONAL FORCE WAS NOT APPLIED TO PRODUCT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284325 BONE HOLDING FORCEPS SELF-CENTER SOFTLO HTD SYNTHES GMBH 5910593

    Patients

    Seq Age Sex Outcome Treatment
    1