BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 3130618 · Received May 24, 2013

    Report

    Report Number
    1719045-2013-01471
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED BY THE PRODUCT DEVELOPMENT ENGINEER AND IT WAS REPORTED: THE RETURNED RIA SHAFT DEVICE (LOT #6921238) WAS MANUFACTURED IN SEPTEMBER 2012. IT APPEARS THAT THE RIA SHAFT DEVICE MAY HAVE BEEN FORCED OFF-AXIS ONCE CONNECTED TO THE REAMER, CAUSING DAMAGE TO THE REAMER SHAFT. THE MATERIAL OF THE DRIVE SHAFT IS NITINOL, WHICH IS ESSENTIAL TO THE FLEXIBILITY OF THE DRIVE SHAFT. THIS IS AN ADEQUATE MATERIAL FOR THE DRIVE SHAFT. THERE AREN¿T ANY FINISHING PROCESSES OR OTHER TREATMENTS THAT CAN IMPROVE THE PERFORMANCE OF THE SHAFT. OTHER DESIGNS HAVE BEEN CONSIDERED, BUT THE CURRENT DESIGN HAS BEEN DETERMINED TO BE ADEQUATE. REVISION E OF THE DESIGN CLINICAL RISK MANAGEMENT DOCUMENT WAS REVIEWED ((B)(4)). THIS COMPLAINT IS ASSOCIATED WITH LINE 7 FOR A DRIVE SHAFT FAILURE. THE RATE OF OCCURRENCE FOR A DRIVE SHAFT FAILURE IS (B)(4), AND IS CONTROLLED BY THE TECHNIQUE GUIDE AND IN-SERVICES FOR END USERS. THE SEVERITY OF THIS RISK IS SET AT "2, MARGINAL - EFFECT CAUSES MODERATE NUISANCE TO USERS OR PATIENTS, NOT SERIOUS ENOUGH TO CAUSE INJURY OR DAMAGE BUT MAY RESULT IN UNSCHEDULED SURGERY." THE DESIGN AND CLINICAL RISK MANAGEMENT DOCUMENT IS BEING UPDATED TO REFLECT THE CURRENT OCCURRENCE RATE REFLECTED BY THE 5-YEAR COMPLAINT HISTORY AND SALES FIGURES IN THE US AND EUROPE. IN 5 YEARS, THERE HAVE BEEN APPROXIMATELY (B)(4) SALES AND APPROXIMATELY (B)(4) COMPLAINTS, WHICH CORRESPONDS TO A RATE OF OCCURRENCE OF (B)(4). THE SEVERITY OF THE RISK IS ALSO BEING INCREASED, AS MATERIAL LEFT IN THE PATIENT SIGNIFIES A MODERATE (3) SEVERITY OF THE RISK. THIS IS DETERMINED BECAUSE THE RISK TYPICALLY WOULD NOT PERMANENTLY IMPAIR BODILY FUNCTIONS OF THE PATIENT, BUT COULD CAUSE INJURY, ELONGATION OF OR TIME, AND USE OF ANOTHER INSTRUMENT (RISK SEVERITY 3). BECAUSE IT APPEARS THAT THE DEVICE MAY HAVE BEEN FORCED OFF-AXIS ONCE CONNECTED TO THE REAMER, CAUSING DAMAGE TO THE REAMER SHAFT, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE REAMER IRRIGATOR ASPIRATOR WAS DISCOVERED AS BROKEN DURING SURGERY ON (B)(6) 2013. IT WAS STATED THAT THERE WERE NO PART FRAGMENTS, AND IT IS UNKNOWN WHEN IT BROKE AS IT WAS BROKEN BEFORE THE SURGERY BEGAN. WHEN THE SURGEON ATTEMPTED TO REAM THE MEDULLARY CANAL WITH THE REAMER/IRRIGATOR/ASPIRATOR (RIA), VERY LITTLE PROGRESS WAS MADE. THE DEVICE WAS VIEWED UNDER FLUOROSCOPY, IT WAS DISCOVERED THAT THE CUTTING TIP WAS NOT ROTATING DESPITE THE DRILL BEING ENGAGED. THE TIP OF THE SHAFT WHICH INTERFACES WITH THE CUTTING HEAD WAS MISSING, AND THERE WAS OBVIOUS DAMAGE TO THE REMAINING PORTION. NO RETAINED FRAGMENTS OF THE RIA SHAFT WERE VISIBLE ON X-RAY OR DIRECT VISUALIZATION. THIS CAUSE A 45 MIN DELAY IN OPERATION TIME WHILE THE SURGEON REPLACED THE INSTRUMENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232427 13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR HTO SYNTHES MONUMENT 7087712

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention