BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING SMALL

    MDR report key: 3083156 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11128
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    November 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    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. ORIGINAL AWARENESS DATE IS 11/29/2012. PLACEHOLDER.

    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 RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MANUFACTURING EVALUATION REVEALS THAT THE COMPLAINT DEVICE WAS RECEIVED WITH THE END CAP ON THE HANDLE OF THE SCREW DRIVER SEPARATED FROM THE HOLDING MECHANISM. THE END CAP SHOWED MARKS OF HAMMERING. THE END CAP HOLDING JAWS ON THE HANDLE WERE DEFORMED. DUE TO THE DAMAGE, THE DIMENSIONS COULD NOT BE CHECKED TO POST-MANUFACTURING DIMENSIONS. THE INSTRUMENT MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTION. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PRODUCT DEVELOPMENT EVALUATION REPORTS THAT RECEIVED WITH THE END CAP WAS SEPARATED FROM THE HANDLE. THE END CAP SHOWS HAMMERING MARKS. IT WAS ESTABLISHED THAT ON THE RETURNED INSTRUMENT, THE END CAP FELL OFF. HOWEVER, UPON FURTHER INSPECTION IT WAS DETECTED THAT THE WINGS INSIDE OF THE CAP WERE DEFORMED. THE CAP ITSELF SHOWS MARKS WHICH INDICATE THAT A METAL HAMMER WAS USED ON THE INSTRUMENT. EXCESSIVE USE OF A HAMMER MIGHT CAUSE THE WINGS TO BE DEFORMED, HENCE CAUSING DAMAGE OF THE MECHANISM. THE ROOT CAUSE BASED ON THE INFORMATION RECEIVED AND PRODUCT REVIEW IS EXCESSIVE HAMMERING ON THE HANDLE LEADING TO THE DEFORMATION OF THE WINGS. THE INSTRUMENT WAS MISHANDLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF THE HANDLE BROKE OFF DURING AN UNSPECIFIED PROCEDURE. A PIECE OF THE HANDLE FELL TO THE FLOOR. THIS DID NOT IMPACT THE PROCEDURE OR PATIENT. THE SURGEON USED ANOTHER HANDLE TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185424 HANDLE WITH QUICK COUPLING SMALL OVE SYNTHES GMBH 7729574

    Patients

    Seq Age Sex Outcome Treatment
    1