BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI LM/RL TIB AUG SZ4 5MM

    MDR report key: 3033654 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01188
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN IDENTIFIED AS A DUPLICATE OF (B)(4) REPORTED UNDER MFR#0002249697-2013-01166. INVESTIGATION RESULTS AND CONCLUSIONS WILL BE DOCUMENTED ON REFERENCED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO LOCK THE AUGMENT ONTO THE BASEPLATE. WHEN HE USED THE TORQUE WRENCH THE LOCKING MECHANISM SPUN THROUGH AND WOULD NOT LOCK. HE HAD TO CEMENT THE AUGMENT ONTO THE BASEPLATE RESULTING IN INCREASED SURGICAL TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO LOCK THE AUGMENT ONTO THE BASEPLATE. WHEN HE USED THE TORQUE WRENCH THE LOCKING MECHANISM SPUN THROUGH AND WOULD NOT LOCK. HE HAD TO CEMENT THE AUGMENT ONTO THE BASEPLATE RESULTING IN INCREASED SURGICAL TIME. UPDATE: THIS EVENT HAS BEEN IDENTIFIED AS A DUPLICATE OF (B)(4) REPORTED UNDER MFR#0002249697-2013-01166. INVESTIGATION RESULTS AND CONCLUSIONS WILL BE DOCUMENTED ON REFERENCED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136131 TRI LM/RL TIB AUG SZ4 5MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH FJFWA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other