BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIARTICULAR LOCKING SCREW 3.5MM

    MDR report key: 5207320 · Received November 6, 2015

    Report

    Report Number
    1822565-2015-02322
    Event Type
    Malfunction
    Date Received
    November 6, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    HWC
    Removal / Correction Number
    Z-0645-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE INVOLVED: PART #00-2359-014-24, PERIARTICULAR LOCKING SCREW, LOT #62896038. A REVIEW OF DEVICE HISTORY RECORDS FOUND THAT PACKAGING OF THE REPORTED LOTS WAS PERFORMED ON THE SAME DAY BY THE SAME OPERATOR. IT WAS ALSO FOUND THAT THE NON-STERILE BAG SPECIFIED FOR PACKAGING BOTH COMPONENTS IS THE SAME, AND THE LABELING IS PRINTED ON THE BAG AT THE TIME OF THE PACKAGING OPERATION. NO PRODUCT WAS AVAILABLE FOR FURTHER STOCK INVESTIGATION. A DISTRIBUTION HISTORY REPORT INDICATED FURTHER COMINGLING, AS DISTRIBUTION FOR ONE LOT INDICATED MORE ITEMS DISTRIBUTED THEN WHAT WAS MANUFACTURED. IT WAS DETERMINED THAT SOME PIECES OF PART NUMBER 00-2359-014-24 LOT NUMBER 62896038 WERE PACKAGED AND DISTRIBUTED AS PART NUMBER 00-2359-058-35 LOT NUMBER 62918019. THE DEVICE WAS USED FOR TREATMENT. THESE IMPLANTS ARE SOLD AND DISTRIBUTED NON-STERILE. THE ITEMS ARE REMOVED FROM PACKAGING AND STERILIZED PRIOR TO USE. THIS REPORTED ISSUE WAS NOTED AT THE TIME IMPLANTS WERE REMOVED FROM THE PACKAGING, AND WERE NOT ATTEMPTED FOR USE DURING A MEDICAL PROCEDURE. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED. ADDITIONALLY, FIELD ACTION Z-0646-2016 WAS INITIATED ON DECEMBER 8, 2015 TO REMOVE THE AFFECTED PART NUMBER LOT NUMBER COMBINATIONS FROM THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #UNK, UNKNOWN, LOT #UNK. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS NOT THE LOCKING SCREW AS LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737337 PERIARTICULAR LOCKING SCREW 3.5MM HWC HWC ZIMMER INC 62918019

    Patients

    Seq Age Sex Outcome Treatment
    1