BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4033277 · Received August 25, 2014

    Report

    Report Number
    2520274-2014-13248
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    July 29, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR THREE UNKNOWN 5.0MM DYNAMIC LOCKING SCREWS/UNKNOWN LOT. A PARTIAL PART NUMBER OF 09.223.0XXS WAS PROVIDED. IMPLANT DATE: UNKNOWN. EXPLANT DATE: PART OF THE DEVICES WERE LEFT IN THE PATIENT; DEVICES WERE NOT EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THESE FOLLOWING PRODUCTS WERE REPORTED, BUT WE DO NOT KNOW WHICH 3 SCREWS FAILED OF THEM: 3X 09.223.032S LOT 7741001, 3X 09.223.034S LOT 7744607. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER A HEALING/CONSOLIDATION OF A FIFTEEN CENTIMETER BONE DEFECT ON THE TIBIA SHAFT A REMOVAL SURGERY WAS PLANNED. DURING THIS SURGERY (IN (B)(6) OF 2014) THREE BROKEN PINS FROM A 5.0MM DYNAMIC LOCKING SCREW WERE DETECTED. THE BONE DEFECT WAS TREATED WITH TWO PLATES DOUBLE-SIDED AND DISTAL WITH 5.0MM DYNAMIC LOCKING SCREW AND STANDARD LOCKING SCREWS IN THE PROXIMAL AREA. THE SURGEON LEFT THE THREE SLEEVES IN THE PATIENT. THIS REPORT IS FOR THREE UNKNOWN 5.0MM DYNAMIC LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER A HEALING/CONSOLIDATION OF A FIFTEEN CENTIMETER BONE DEFECT ON THE TIBIA SHAFT A REMOVAL SURGERY WAS PLANNED. DURING THIS SURGERY (IN WEEK 30 OF 2014) THREE BROKEN PINS FROM A 5.0MM DYNAMIC LOCKING SCREW (DLS) WERE DETECTED. THE PINS FROM THE DLS SCREWS WERE BROKEN. THE SCREW SLEEVES ARE COVERED WITH BONES. THE BONE DEFECT WAS TREATED WITH TWO PLATES DOUBLE-SIDED AND DISTAL WITH 5.0MM DYNAMIC LOCKING SCREW AND STANDARD LOCKING SCREWS IN THE PROXIMAL AREA. THE SURGEON LEFT THE THREE SLEEVES IN THE PATIENT. THIS REPORT IS FOR THREE UNKNOWN 5.0MM DYNAMIC LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511358 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1