BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW, RECON T2 RECON Ø6.5X105 MM

    MDR report key: 4180032 · Received October 17, 2014

    Report

    Report Number
    0009610622-2014-00558
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED ITEM WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DHR FOR LAG SCREW, RECON T2 RECON Ø6.5X105 MM, CATALOGUE # 18976105S AND LOT # K268749 REVEALED NO DISCREPANCY. ALTHOUGH REPEATEDLY REQUESTED PRODUCT DETAILS (CATALOGUE NUMBER AND LOT CODE) OF THE LOCKING SCREW THAT ALLEGEDLY HAD BEEN IN THE PACKAGING OF THE RECON LAG SCREW WERE NOT AVAILABLE. THUS THE SCREW ONLY CAN BE ASSUMED TO BE POTENTIALLY OF CATALOGUE NUMBER 18965090S; WHICH IS FINALLY NOT BEING CONFIRMED. THE DHRS FOR ARTICLE 18965090S WHICH WERE PRODUCED AT THE SAME TIME AS THE RECON LAG SCREW WERE REVIEWED. THE REVIEW EXCLUDED A POTENTIAL MIX UP DURING PACKAGING FOR THE TIME OF MANUFACTURING OF THE RECON LAG SCREW (MARCH 2010). LOT K268749 WAS PACKAGED BY STRYKER (B)(4) WHEREAS LOCKING SCREWS WERE PACKAGED BY A SUPPLIER. IN THIS CASE IT COULD ONLY BE REFERRED TO AVAILABLE INFORMATION. A FURTHER STATEMENT WAS NOT POSSIBLE. WITH AVAILABLE INFORMATION THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FILE WILL BE CLOSED FORMALLY AND CAN BE REOPENED WHEN SUBSTANTIVE INFORMATION OR THE ITEM(S) BECOME AVAILABLE. WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT FEMUR SURGERY, DOCTOR OPENED THE BOX FOR A 6.5 X 105MM LAG SCREW FOR THE RECON NAILING SYSTEM. WHEN HE OPENED UP THE PLASTIC, THE WRONG SCREW WAS IN THE BOX. INSTEAD OF A 6.5 X 105MM LAG SCREW, THERE WAS A 5 X 90 MM LOCKING SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT FEMUR SURGERY, DOCTOR OPENED THE BOX FOR A 6.5 X 105MM LAG SCREW FOR THE RECON NAILING SYSTEM. WHEN HE OPENED UP THE PLASTIC, THE WRONG SCREW WAS IN THE BOX. INSTEAD OF A 6.5 X 105MM LAG SCREW, THERE WAS A 5 X 90 MM LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662926 LAG SCREW, RECON T2 RECON Ø6.5X105 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K268749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other