BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS 3.5 3HO SST

    MDR report key: 3222298 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04304
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTW
    PMA / PMN Number
    K011815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PART WAS RETURNED TO MANUFACTURER ON 07/02/2013. AN ADDITIONAL EVALUATION/INVESTIGATION WAS PERFORMED AND COORDINATED BY SYNTHES (B)(4), AND THE REPORT STATES THE FOLLOWING: THE INVESTIGATION HAS SHOWN THAT THE STABILIZATION PIN IS NOT IN ITS INITIAL POSITION AND THE CONNECTING SCREW IS DAMAGED. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED CONDITIONS WERE FOUND. ALTHOUGH THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED, THE COMPLAINT CONDITION IS LIKELY THE RESULT OF TECHNICAL COMPLICATIONS DURING THE ASSEMBLING OF THE PHILOS AIMING SYSTEM.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE (DATE UNKNOWN), THE SURGEON IMPLANTED A THREE HOLES PROXIMAL HUMERAL PLATE IN THE PATIENT (GOOD REDUCTION), BUT REALIZED THERE WERE NOT ENOUGH HOLES. THE SURGEON THEN DECIDED TO USE ANOTHER PLATE (FIVE HOLES PROXIMAL HUMERAL PLATE), BUT COULD NOT REMOVE THE THREE HOLES PLATE FROM THE AIMING ARM. IT WAS ALSO REPORTED THE SURGEON IMPLANTED THE FIVE HOLE PLATE WITHOUT USING THE INSERTION HANDLE FOR PHILOS, AND INSTEAD USED A LOCKING DRILL SLEEVE 2.8MM (PERCUTANEOUS) DIRECTLY ON THE PLATE. THERE WAS A DELAY IN SURGERY FOR THIRTY MINUTES; WITH NO ADVERSE EVENT TO PATIENT OR ADDITIONAL TREATMENT NEEDED. THIS IS 2 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321547 PHILOS 3.5 3HO SST KTW SYNTHES GMBH 7855016

    Patients

    Seq Age Sex Outcome Treatment
    1