BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANSSON PIN TI 85MM

    MDR report key: 3071549 · Received April 22, 2013

    Report

    Report Number
    0008031020-2013-00107
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K033968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE NO CONCLUSION COULD BE MADE HOW AND WHEN THE FAILURE OCCURRED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. PLEASE NOTE THAT THE CURRENT OP TECH READS: ASSEMBLY: "VERIFY THAT THE INNER PIN DOES NOT PROTRUDE FROM THE WINDOW OF THE OUTER BODY AND IS IN CORRECT POSITION." INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS FOUND UPON OPENING THE PACKAGE THAT THE HOOK WAS ALREADY OUT ABOUT 2MM. A BACKUP (SAME SIZE) WAS USED.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS FOUND UPON OPENING THE PACKAGE THAT THE HOOK WAS ALREADY OUT ABOUT 2MM. A BACKUP (SAME SIZE) WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171280 HANSSON PIN TI 85MM IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH T135525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other