BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10° X3 INSERT 28MM ID

    MDR report key: 3807895 · Received May 13, 2014

    Report

    Report Number
    0002249697-2014-01813
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PRODUCT MIX INVOLVING TRIDENT PSL WITH PUREFIX HA PACKAGING AND A TRIDENT 10° X3 INSERT DEVICE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED DEVICE AND PACKAGING WAS RECEIVED. THE OUTER BOX LISTED A TRIDENT SHELL (CATALOG: 542-11-42B, LOT ID: 38900101). THE OUTER BOX CONTAINED UNOPENED INNER BLISTER PACKS FOR A TRIDENT INSERT (PART NUMBER: 623-10-28F, LOT:39222901). INDENTATIONS WERE IDENTIFIED ON THE OUTER BOX. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAS BEEN ONE OTHER EVENT FOR THE LOT REFERENCED. PR 236707 REPORTED A POTENTIAL PRODUCT MIX, ALSO FROM MEXICO. PR 236707 INCLUDES THE SAME LOT NUMBER AND PART NUMBER REFERENCED IN THIS INVESTIGATION EXCEPT THAT THE OUTER BOX LISTED A TRIDENT INSERT (PART NUMBER: 623-10-28F, LOT:39222901) AND THE DEVICE WAS A TRIDENT SHELL (CATALOG: 542-11-42B, LOT ID: 38900101.) THIS INVESTIGATION IS BEING CLOSED TO PI 232779, WHICH CONCLUDED THAT THE REPORTED PARTS WERE NOT INVOLVED IN A MANUFACTURING RELATED PRODUCT MIX. IT WAS DETERMINED THAT BOTH THE PARTS WERE NOT IN THE SAME AREA OF THE PLANT AT ANY TIME DURING PRODUCTION OR STERILIZATION, FURTHER TO THIS THE PARTS WERE PACKAGED TWO WEEKS APART THUS PROVIDING ASSURANCE THAT THIS IS NOT A MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING SURGERY, THEY TRY TO USE PART NUMBER 542-11-42B, LOT: 38900101, SN : (B)(4), BUT WHEN THEY OPEN THE BOX THE PRODUCT ACTUALLY WAS PART NUMBER 623-10-28F, LOT: 39222901.

    Description of Event or Problem · 1

    DURING SURGERY, THEY TRY TO USE PART NUMBER 542-11-42B, LOT: 38900101, SN : (B)(4), BUT WHEN THEY OPEN THE BOX THE PRODUCT ACTUALLY WAS PART NUMBER 623-10-28F, LOT: 39222901.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286093 TRIDENT 10° X3 INSERT 28MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 39222901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other