BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW, STST 10.5X95MM

    MDR report key: 1884555 · Received October 21, 2010

    Report

    Report Number
    9610622-2010-00448
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DIMENSIONAL EXAMINATION OF THE LAG SCREW WITH OUTSIDE MICROMETER REVEALED THAT THE DIAMETER OF THE LAG SCREW IS OVERSIZED. THE LAG SCREW COULD NOT BE INSERTED INTO THE RETURNED NAIL. THE LAG SCREW COULD ALSO NOT BE INSERTED INTO SAMPLE NAIL. THE DIMENSION OF THE PROXIMAL HOLE OF THE RETURNED NAIL IS ALSO OVERSIZED DUE TO THE MATERIAL DEFORMATION. A REVIEW OF THE DHR FOR THE LAG SCREW (LOT CODE K175571) REVEALED NO DISCREPANCIES. THE REVIEW OF THE MANUFACTURING DOCUMENTS OF THE LAG SCREW AND OF THE RETURNED NAIL REVEALED NO DEVIATION. THE FUNCTION TEST OF THE LAG SCREW WITH SAMPLE NAIL REVEALED THAT THE LAG SCREW COULD NOT BE INSERTED INTO GAMMA3 NAILS. THE DIMENSIONAL EXAMINATION REVEALED THAT THE DIAMETER OFT HE LAG SCREW IS OVERSIZED. EVALUATION REVEALED THAT THE OVERSIZED LAG SCREW PRESENTS A NON-CONFORMITY AS THE PRODUCT FAILED TO MEET ITS SPECIFICATION. EVALUATION REVEALED THAT THE REPORTED EVENT IS LINKED TO A MANUFACTURING ERROR (THAT WAS NOT DETECTED BY INSPECTION). THE DIAMETER OF THE LAG SCREW IS OVERSIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAG SCREW COULDN'T BE PASSED THROUGH THE NAIL'S HOLE. SURGEON USED ANOTHER AVAILABLE PRODUCTS (NAIL + SCREW) WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW, STST 10.5X95MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA 175571

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other