BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAT ASSEMBLY, RAD STEM IMPLANT,COLLAR 6MM,SIZE2

    MDR report key: 6828653 · Received August 29, 2017

    Report

    Report Number
    0008031020-2017-00502
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 7, 2017
    Report Date
    October 5, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    KWI
    PMA / PMN Number
    K062898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE LABEL ON THE PACKAGE OF A LAT ASSEMBLY, RAD STEM IMPLANT,COLLAR 6MM,SIZE2 REPORTED "310-0005" AND THAT THE DEVICE INSIDE WAS "311-0507" COULD BE CONFIRMED. THE COMPLAINT INVESTIGATION REVEALED THAT THIS IS INTENTIONAL. "311-0507" IS THE DEVICE IDENTIFIER, "310-0005" IS THE SYSTEM ONE (INCLUDING LABELS, PACKAGING, ETC.). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PERFORMING A PROCEDURE FOR A RADIAL HEAD REPLACEMENT PROCEDURE, REP OPENED A PACKAGE LABELLED AS CAT # 310-005. INSIDE THE BOX WAS CAT # 311-0507, LOT 071720. REP REPORTED THAT GETTING THE CORRECT DEVICE CAUSED A 20-30 MINUTE SURGICAL DELAY. ORIGINAL BOX WAS DISCARDED BUT REP CAN OBTAIN THE BOX STICKERS. INCORRECT PART IS AVAILABLE FOR RETURN. SURGICAL DELAY OF 20-30 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PERFORMING A PROCEDURE FOR A RADIAL HEAD REPLACEMENT PROCEDURE, REP OPENED A PACKAGE LABELLED AS CAT # 310-005. INSIDE THE BOX WAS CAT # 311-0507, LOT 071720. REP REPORTED THAT GETTING THE CORRECT DEVICE CAUSED A 20-30 MINUTE SURGICAL DELAY. ORIGINAL BOX WAS DISCARDED BUT REP CAN OBTAIN THE BOX STICKERS. INCORRECT PART IS AVAILABLE FOR RETURN. SURGICAL DELAY OF 20-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606471 LAT ASSEMBLY, RAD STEM IMPLANT,COLLAR 6MM,SIZE2 ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS KWI STRYKER GMBH 10163-L19

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other