BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE OFFSET RASP HANDLE

    MDR report key: 5127064 · Received October 5, 2015

    Report

    Report Number
    0002249697-2015-03240
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Removal / Correction Number
    2249697-11/11/10-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACKING/FRACTURING INVOLVING AN ACCOLADE HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE RETURNED PARTS WERE EXAMINED WITH THE AID OF A STEREO MICROSCOPE AT MAGNIFICATIONS UP TO 50X. THE FRACTURE SURFACE ASSOCIATED WITH THE IMPACTION PAD WAS EXAMINED USING A SCANNING ELECTRON MICROSCOPE (SEM). SEM ANALYSIS SHOWED THAT THE FILLET WELD THAT HELD THE IMPACTION PAD TO THE RASP HANDLE BODY BROKE FROM OVERLOAD CONDITIONS IN A RAPID MANNER. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT WAS CONFIRMED. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT (B)(4) RESULTED IN REGULATORY ACTION RA2009-050 (APPROVED NOV. 1, 2010) WHICH RECALLED THE DEVICE FOR THE POTENTIAL FRACTURING/BREAKAGE OF THE STRAIGHT RASP HANDLE. ALL LOTS WERE RECALLED. THE DEVICE REPORTED IN THIS EVENT WAS MANUFACTURED BEFORE THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE WAS BROKEN DURING IMPACTION TO REMOVE THE RASP FROM THE BONE AFTER RASPING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE WAS BROKEN DURING IMPACTION TO REMOVE THE RASP FROM THE BONE AFTER RASPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660021 ACCOLADE OFFSET RASP HANDLE HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE MAY STRYKER ORTHOPAEDICS-MAHWAH P3S86

    Patients

    Seq Age Sex Outcome Treatment
    1 Other