BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEORAPTOR 2.9 MM A

    MDR report key: 1932267 · Received December 17, 2010

    Report

    Report Number
    1219602-2010-00311
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 17, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES ARE BEING RETURNED FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    CUSTOMER WANTED TO USE THE OSTEORAPTOR ANCHOR, BUT THE FIRST 3 HE TRIED TO USE SHATTERED UPON INSERTION AND THE FOURTH WAS SUCCESSFUL. ANCHOR SPLIT IN HALF UPON INSERTION. PRODUCT INCIDENT REPORT CONFIRMS THAT THE PIECES WERE REMOVED FROM THE PATIENT AND NO PATIENT INJURY RESULTED. SURGEON FOLLOWED THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEORAPTOR 2.9 MM A OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE HWC SMITH & NEPHEW ENDOSCOPY 72201995 50318532

    Patients

    Seq Age Sex Outcome Treatment
    1