BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HIP CURVE

    MDR report key: 1830287 · Received September 10, 2010

    Report

    Report Number
    1219602-2010-00221
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 11, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE RETURNED BLADE WAS EVALUATED AND THE OUTER BLADE TIR WAS OBSERVED TO BE .033 AND THE INNER BLADE WAS OBSERVED TO RUN OUT .022. THE BLADE WAS OBVIOUSLY BENT BEYOND TIR REQUIREMENTS. SINCE THE WELDED TIP HAD SNAPPED AT THE WELD, IT IS LIKELY THAT THE FORCE APPLIED TO THE BLADE CAUSED THE BLADE TO BEND AND THE TIP WELD TO SNAP. NO FIRM CONCLUSION CAN BE MADE AS TO WHEN THE BLADE BECAME BENT. (B)(4)

    Description of Event or Problem · 1

    THE TIP OF THE SHAVER BLADE BROKE INSIDE PATIENT. THE PIECE WAS REMOVED APPROXIMATELY 10 DAYS AFTER ORIGINAL SURGERY. THEY HAD TO OBTAIN SOME LONG HAND HELD INSTRUMENTS (HIP INSTRUMENTS) TO REMOVE IT. THE ORIGINAL PROCEDURE WAS NOT ABANDONED. THE ONLY PROBLEM WAS THEY HAS TO OPEN THE PATIENT AGAIN TO REMOVE THE PIECE THEY HAD TO LEAVE AS THEY COULD NOT REACH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HIP CURVE FULL RADIUS BL,CONCAVE EP-1 (BX 3) HAB SMITH & NEPHEW ENDOSCOPY 7205335 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention