BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS

    MDR report key: 4806578 · Received May 29, 2015

    Report

    Report Number
    1000562954-2015-10113
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    PMA / PMN Number
    PK000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART 04.005.546, LOT 7881105: A PRODUCT EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED INTACT. IT IS MADE OF (B)(4) ALLOY. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AGE NOT REPORTED. EVENT DATE: UNKNOWN WHEN PAIN STARTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. MANUFACTURING DATE: 20. APRIL 2012, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AN INVESTIGATION SUMMARY WAS ATTEMPTED, PER INVESTIGATION SITE, IT WAS NOT POSSIBLE DUE THE MISSING MATERIAL/ PRODUCTS WERE NOT RETURNED. 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PROCEDURE WAS DONE, REVISION OF A2FN. PATIENT HAD A2FN IN THE RIGHT FEMUR DONE ON THE (B)(6) 2013. CAME BACK AND COMPLAINT OF PAIN ON THE RIGHT FEMUR ON (B)(6) 2015, X RAY DONE AND BROKEN SCREW OF THE DISTAL SCREW. FURTHER QUESTIONING AND PAIN IS LOCALISED ON THE NON-UNION OF THE FEMUR. PATIENT'S REVISION SURGERY IS DONE ON (B)(6) 2015, ANOTHER NEW A2FN NAIL IS INSERTED. SURGEON MENTIONED THE BROKEN SCREW MOST LIKELY DUE TO THE NON-UNION. OTHER THAN THAT, PATIENT IS HEALTHY AND SURGERY WENT WELL. PATIENT OUTCOME POST PROCEDURE IS GOOD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348534 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS SCREW, FIXATION, BONE HWC SYNTHES MEZZOVICO 7881105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention