BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE SENTINEL INTRAMEDULLARY FLEXIBLE REA

    MDR report key: 1675640 · Received May 5, 2010

    Report

    Report Number
    1822565-2010-00268
    Event Type
    Injury
    Date Received
    May 5, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 6, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: SURGICAL TECHNIQUE AND/OR PACKAGE INSERT INDICATES THE USE OF GUIDE WIRE TO ENSURE PROPER GUIDANCE OF THE REAMING HEAD AND TO FACILITATE REMOVAL OF REAMER HEAD IF IT GETS DISLODGED FROM THE SHAFT. TO AVOID REAMER GETTING LODGED DURING USE, THE REAMER SHOULD BE IMMEDIATELY STOPPED AND RETRACTED WHEN THERE IS TOO MUCH RESISTANCE. IT IS ALSO SUGGESTED THAT REPEATED CLEANING OF ANY ADHERING BONE IS REQUIRED IF THE BONE IS VERY HARD. SINCE THE REAMER IS FLEXIBLE, ANY OFF-AXIS LOADING COULD HAVE CREATED HIGH TENSILE STRESSES. THE CONDITIONS INDICATING HOW THE REAMER WAS INSERTED AND LOADED IN THE BONE CANAL DURING SURGERY ARE UNKNOWN. IT IS UNKNOWN WHETHER THE GUIDE WIRE WAS USED. FROM THE DESCRIPTION OF PER IT APPEARS THAT THE GUIDE WIRE WAS NOT USED. THERE IS INSUFFICIENT INFORMATION PROVIDED IN THE PER TO DETERMINE THE ROOT CAUSE. THE SENTINEL REAMER WAS RETURNED WITHOUT THE TIP BECAUSE, AS REPORTED, IT WAS LEFT IN THE PATIENT. NO DAMAGE WAS FOUND ON THE REAMER SHAFT INDICATING THAT THE TIP SLID OFF. THE DIAMETER OF THE REAMER SHAFT WAS FOUND TO BE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING TO MANUFACTURING, INSPECTION, AND PACKAGING PROCESSES. THE INSTRUMENT HAD A POTENTIAL FIELD AGE OF APPROXIMATELY 7 YEARS AT THE TIME OF FAILURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE REAMER TIP CAME OFF WHILE REAMING THE ULNA. ATTEMPTS WERE MADE TO REMOVE WITH GRASPERS BUT IT WAS DECIDED TO LEAVE IT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE SENTINEL INTRAMEDULLARY FLEXIBLE REA TRAUMA INSTRUMENT HTO ZIMMER, INC. NA 42227600

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other