BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8MM VA LOCKING BUTTRESS PIN W/T8 STARDRIVE RECESS/20MM

    MDR report key: 3090571 · Received May 2, 2013

    Report

    Report Number
    2520274-2013-02274
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THESE PARTS WHEN CONSIDERED AS A WHOLE WOULD CONSTITUTE A VARIABLE ANGLE LOCKING BUTTRESS PIN. SPECIFICALLY, A LOCKING HEAD WITH STARDRIVE RECESS AND PLAIN SHAFT WITH THREADS NEAR THE HEAD IDENTIFY THIS AS A BUTTRESS PIN. THE CALCULATED LENGTH OF 20.55MM WOULD MAKE THIS A 02.210.090. PLEASE NOTE THAT THERE IS NO COMBINATION OF SHAFTS AND HEADS PROVIDED THAT WOULD YIELD A 02.210.086 SINCE THE SHORTEST SHAFT, WITHOUT A HEAD, IS 16.09MM, THE TOTAL LENGTH OF A 02.210.086 IS 16MM. THE DRIVE IS IN GOOD CONDITION WITH LITTLE OR NO MARKINGS. THE TOP OF THE HEAD IS ALSO IN GOOD CONDITION. THE HEAD THREADS HAVE BEEN LIGHTLY DAMAGED NEAR THE TRANSITION WITH THE MAJOR BEING BENT SLIGHTLY UPWARDS TOWARDS THE TOP OF THE HEAD. THE BREAK IS AT THE NECK AND APPEARS TO BE CLEAN WITH NO INVOLVEMENT OF THE DRIVE. THE SHAFT THREADS HAVE SMALL INDENTATIONS, CONSISTENT WITH AN EXTRACTION. THE THREADLESS PORTION OF THE SHAFT IS IN GOOD CONDITION. THE TIP RADIUS HAS A SMALL MARK THAT APPEARS TO BE A MINOR ABRASION. THE DIMENSIONS THAT COULD BE MEASURED ARE IN TOLERANCE. DUE TO THE TYPE AND EXTENT OF DAMAGE INCURRED, AND ALSO BECAUSE NO LOT NUMBER WAS PROVIDED, A FINITE EVALUATION WAS NOT POSSIBLE. CORRECT PART NUMBER FOUND IN MANUFACTURING EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN AFTER FALLING FROM BED. DURING A DISTAL RADIUS REVISION SURGERY ON (B)(6) 2013, IT WAS DISCOVERED THAT TWO VARIABLE ANGLE LOCKING BUTTRESS PINS WERE SHEARED OR BROKEN AT THE HEAD OF THE PLATE. THIS OCCURRED AT THE JUNCTION WHERE THE SHAFT MEETS THE HEAD OF THE PIN. THE HEADS OF THE PINS REMAINED LOCKED IN THE PLATE. THE PINS WERE EXPLANTED. NO NEW HARDWARE WAS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192212 1.8MM VA LOCKING BUTTRESS PIN W/T8 STARDRIVE RECESS/20MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention