BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 3123690 · Received May 22, 2013

    Report

    Report Number
    0009610622-2013-00279
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE COMPRESSION SCREW WAS CLASSIFIED AS PRIMARY PRODUCT. ALL OTHER IMPLANTS ARE ASSOCIATED PRODUCTS AND WILL BE NOT CONSIDERED IN THE INVESTIGATION SUMMERY. THE IMPLANTS ARE NOT AVAILABLE, FURTHERMORE THE PRODUCT DETAILS (CATALOG NUMBERS AND LOT CODES) WERE NOT PROVIDED. THEREFORE AN INVESTIGATION OF THE PRODUCTS THEMSELVES AND A REVIEW OF THE DHR WERE NOT POSSIBLE. BASED ON THE RETURNED X-RAYS THE ASSUMPTION OF THE SURGEON IS CORRECT: THE DISTAL SCREW INSERTED IN THE DISTAL LONG HOLE OF THE NAIL WAS NOT COMPRESSED. IT IS POSSIBLE THAT FRACTURE PARTS OF THE BONE HAD MICRO MOVEMENT AND MAYBE CAUSED THE BROKEN SCREW IN THE MOST DISTAL NAIL HOLE DUE TO SEVERAL AXIAL LOADS. PATIENT CONDITIONS AND/OR MOBILIZATION COULD HAVE ALSO CONTRIBUTED TO THE ISSUE. A MORE PRECISE EVALUATION WAS NOT POSSIBLE DUE TO MISSING PRODUCTS AND INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF A LEFT ANKLE NAIL THE DOCTOR THOUGH THAT THE COMPRESSION SCREW FOR THE LAG SCREW WAS NOT TIGHTEN ENOUGH. OVER TIME THE LAG SCREW BACKED OUT AND THE PATIENT COLLAPSED. PATIENT WAS REVISED WITH BIOLOGICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF A LEFT ANKLE NAIL THE DOCTOR THOUGH THAT THE COMPRESSION SCREW FOR THE LAG SCREW WAS NOT TIGHTEN ENOUGH. OVER TIME THE LAG SCREW BACKED OUT AND THE PATIENT COLLAPSED. PATIENT WAS REVISED WITH BIOLOGICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226080 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention