BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BOLT DRIVER

    MDR report key: 3984178 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03012
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A UNIVERSAL BOLT DRIVER WAS REPORTED. CONCLUSION: THE REPORTED EVENT INDICATES THAT THE IMPACTOR BOLT GOT STUCK IN THE CUP AFTER IMPACTION SO A BOLT DRIVER WAS USED TO TRY TO REMOVE THE BOLT. IT WAS REPORTED THAT THE DRIVER WAS BROKEN TRYING TO REMOVE THE BOLT. VISUAL INSPECTION OF THE RETURNED DRIVER DID NOT INDICATE ANY DAMAGES. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUP IMPACTOR BOLT GOT STUCK IN CUP AFTER IMPACTION. U-JOINT BOLT DRIVER WAS USED TO TRY TO REMOVE BOLT. U-JOINT BOLT DRIVER HANDLE WAS BROKEN TRYING TO REMOVE THE BOLT. CUP WAS REMOVED WITH BOLT ATTACHED TO IT USING THE CURVED IMPACTION HANDLE. ANOTHER CUP WAS IMPLANTED USING A DIFFERENT IMPACTION DEVICE.

    Description of Event or Problem · 1

    CUP IMPACTOR BOLT GOT STUCK IN CUP AFTER IMPACTION. U-JOINT BOLT DRIVER WAS USED TO TRY TO REMOVE BOLT. U-JOINT BOLT DRIVER HANDLE WAS BROKEN TRYING TO REMOVE THE BOLT. CUP WAS REMOVED WITH BOLT ATTACHED TO IT USING THE CURVED IMPACTION HANDLE. ANOTHER CUP WAS IMPLANTED USING A DIFFERENT IMPACTION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461484 UNIVERSAL BOLT DRIVER INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH DC239168

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other