BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY ACCOLADE HIP DA DUAL OFFSET BROACH HANDLE SET PER FILE H1698

    MDR report key: 3870574 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02214
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A SPECIALTY ACCOLADE HIP DA DUAL OFFSET BROACH HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS WAS PERFORMED AND FOUND THAT THE WELD AROUND THE TRIGGER PAD DID NOT MEET THE MINIMUM SPECIFICATION FOR WELD SIZE OF 0.050 INCHES AND ALSO FOUND NO EVIDENCE OF A PRESS FIT BETWEEN THE TRIGGER AND THE TRIGGER PAD. A DIMENSIONAL INSPECTION WAS PERFORMED AND FOUND THAT THE PRESS FIT HOLE LOCATED ON THE BOTTOM OF THE TRIGGER WAS OVERSIZED. MEDICAL RECORDS RECEIVED AND EVALUATION: THERE ARE NO EVIDENCE PATIENT FACTORS WERE INVOLVED IN THE REPORTED EVENT. COMPLAINT HISTORY REVIEW: THE COMPLAINT DATABASES SHOW THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE DRAWINGS FOR THE DEVICE CALL FOR A PRESS FIT PIN WHICH MATES THE TRIGGER PAD TO THE TRIGGER AND ALSO CALLS FOR A CONTINOUS WELD AROUND THE TRIGGER PAD. THE MATERIAL ANALYSIS PERFORMED ON THE DEVICE FOUND THAT THE WELD DID NOT MEET THE MINIMUM SPECIFICATION FOR WELD SIZE OF 0.050 INCHES AND ALSO FOUND NO EVIDENCE OF PRESS FIT. A DIMENSIONAL INSPECTION WAS PERFORMED AND DETERMINED THAT THE PRESS FIT HOLE WAS OVERSIZED CONFIRMING THE LACK OF PRESS FIT. THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY SURGERY OF LEFT HIP, TRIGGER BROACH BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY SURGERY OF LEFT HIP, TRIGGER BROACH BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348014 SPECIALTY ACCOLADE HIP DA DUAL OFFSET BROACH HANDLE SET PER FILE H1698 INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH AP6K27

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other