BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP IMPACTOR BOLT

    MDR report key: 3984175 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03013
    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
    MEH
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING DISASSEMBLY ISSUES INVOLVING A CUP IMPACTOR BOLT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE INDICATES THERE IS ABRASION AT THE BASE OF THE THREADED REGION OF THE RETURNED DEVICE. DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE REPORTED EVENT DOES NOT INDICATE AN ISSUE WITH THE DIMENSIONS OF THE DEVICE. WHEN THE DEVICE WAS RECEIVED IT COULD NOT BE DISASSEMBLED, BUT ONCE DISASSEMBLED THE DEVICE IS FULLY FUNCTIONAL. -DEVICE HISTORY REVIEW: INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: 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. THIS CAUSED A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES. MATERIAL ANALYSIS OF THE RETURNED DEVICE INDICATES THAT A FORCE GREATER THAN HAND TIGHT WAS APPLIED TO ENGAGE THE BOLT AND THE CUP. THIS IS THE REASON FOR THE INABILITY TO DISASSEMBLE THE BOLT FROM THE CUP.

    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
    461483 CUP IMPACTOR BOLT INSTRUMENT MEH STRYKER ORTHOPAEDICS-MAHWAH DC232516

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other