BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2640516 · Received June 21, 2012

    Report

    Report Number
    1644408-2012-00307
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWC
    PMA / PMN Number
    K931665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL INCIDENT REPORTED WAS WHEN THE OPERATING ROOM TECHNICIAN OPENED THE PACKAGING THE PART WAS SHORTER THAN THE LABEL DESCRIBED. THE PART WAS MEASURED AND IDENTIFIED AS SMALLER AT 20MM; UPON RETURN TO DJO SURGICAL THE PART WAS IDENTIFIED TO BE A 25MM BONE SCREW. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE CANCELLOUS BONE SCREW SIZE 30MM WAS REVIEWED. A QUANTITY OF 25 WAS MANUFACTURED. ALL PRODUCT COUNTS WERE CORRECT THROUGHOUT THE OPERATIONS, NO SCREWS WERE SCRAPPED AND LABELS WERE PRINTED TO ACCOUNT FOR THE QUANTITY. ALL PART VERIFICATIONS HAD THE CORRECT MEASUREMENT AT THE LASER MARK, PART VERIFY, AND FLOWBENCH FOR THE SIZE 30 MM SCREW. ON JUNE 6, 2012 A RETURN OF MATERIAL AUTHORIZATION (RMA) WAS ISSUED FOR THE RETURN OF THE SCREW TO DJO SURGICAL FOR FULL INVESTIGATION. THE 25 CANCELLOUS BONE SCREWS THAT WERE MISLABELED AS SIZE 25MM, PART NUMBER 010-55-025, LOT 006A1057 WERE ALL LOCATED WITHIN FINISHED GOODS INVENTORY AND WERE QUARANTINED PER HEALTH HAZARD EVALUATION NUMBER (B)(4) AND SUBSEQUENTLY RECALLING THE AFFECTED PRODUCT IN THE FIELD PER DJO SURGICAL INTERNAL RECALL IDENTIFICATION NUMBER 1644408-07/16/2012-001R. THE OPENING OF SEVERAL OF THESE 25MM BONE SCREW BOXES CONFIRMED THAT INSIDE THE PACKAGES WERE 30MM BONE SCREWS, PART NUMBER 010-55-030, LOT 007A1037. OF THE (B)(4) CANCELLOUS BONE SCREWS MISLABELED AS 30MM, SIX WERE IMPLANTED PRIOR TO NOTIFICATION TO THE FIELD, ONE WAS SENT BACK TO DJO SURGICAL WITH THIS PRODUCT COMPLAINT, AND THE REMAINING (B)(4) WERE RECALLED PER INTERNAL RECALL IDENTIFICATION NUMBER 1644408-07/16/2012-001R. THE ROOT CAUSE FOR THIS PRODUCT COMPLAINT IS THERE WAS A CLEANROOM PROCESSING ERROR WHICH OCCURRED AFTER THE CLEANLINE OPERATION AND BEFORE THE FLOWBENCH OPERATION CREATING THE FOLLOWING DISCREPANCIES: THE WORK ORDER AND PRODUCT LABELS WERE CORRECT AND MATCHED, BUT WERE WITH THE WRONG LOT OF SCREWS, AND THE WORKORDER AND SCREWS WERE CORRECT AND MATCHED, BUT WITH THE WRONG LOT OF PRODUCT LABELS, THERE WAS ALSO OPERATOR PROCESSING ERROR FOR NOT FOLLOWING THE APPROPRIATE WORK INSTRUCTION (WI #47), FOR THE FLOWBENCH PART VERIFICATION PROCESS. A CORRECTIVE AND PREVENTATIVE ACTION, CAPA NUMBER 2012-00015 WAS ISSUED AND RETRAINING OF PERSONNEL WAS PERFORMED.

    Description of Event or Problem · 1

    PRIMARY SURGERY - WHEN THE OPERATING ROOM TECHNICIAN OPENED THE PACKAGING FOR THE BONE SCREW, THEY NOTICED THAT THE PART WAS SHORTER THAN THE LABELED 30MM, HE MEASURED THE SCREW AND IT WAS IDENTIFIED AS A 20MM SCREW. AFTER BEING RETURNED TO DJO, THE SCREW WAS LABELED AS A 25MM BONE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP CANCELLOUS BONE SCREW HWC ENCORE MEDICAL, L.P. 007A1037

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention