BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUPLING SCREW FOR INSERTION OF DHS BLADES

    MDR report key: 6102421 · Received November 15, 2016

    Report

    Report Number
    2520274-2016-15383
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4) LOT UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT SURGERY FOR THE PROXIMAL FEMORAL FRACTURES. AS PART OF THE SURGERY KIT THAT WAS PLANNED TO BE USED IN THE SURGERY, CONNECTING SCREW NEEDED TO BE ASSEMBLED. HOWEVER THE THIRD PARTY DISTRIBUTOR AND NURSES NOTICED THAT THE CONNECTING SCREW WAS MISSING JUST BEFORE THE SURGERY BEGAN. NURSE HAD ALREADY PREPARED THE SURGERY WITH STERILIZING TREATMENT. SURGEON PROCEEDED WITH THE SURGERY WITHOUT USING THE CONNECTING SCREWS FOR DHS BLADE; THE SURGEON INSERTED THE DHS BLADE AND FIXED IT. SURGEON HAD TO ALTER THE INTENDED PRODUCT DUE TO NOT BEING ABLE TO USE THE SCREW. SURGERY WAS EXTENDED THIRTY (30) MINUTES. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) COUPLING SCREW FOR INSERTION OF DHS BLADES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754030 COUPLING SCREW FOR INSERTION OF DHS BLADES MISC ORTHO SURGICAL INSTR LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention