BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM

    MDR report key: 3349249 · Received September 16, 2013

    Report

    Report Number
    0009610622-2013-00511
    Event Type
    Malfunction
    Date Received
    September 16, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 19, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVIATIONS IN THE MANUFACTURING DOCUMENTS WERE NOT FOUND. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY IN THE DEVICE BUT IS RATHER RELATED TO OFF-LABEL USE. IT IS IN THE RESPONSIBILITY OF THE USER TO CHECK THE SHELF- LIFE PRIOR TO USE. STERILE PACKAGED (READY TO USE) MEDICAL DEVICES WHICH PAST ITS EXPIRY DATE SHOULD HAVE BEEN DETECTED PRIOR TO USE. IN THE CASE PRESENTED A DRILL F. RADIOLUCENT TARGETING DEVICE WAS USED WHICH STERILIZATION DATE WAS EXCEEDED BY APPROX. 2 MONTHS (EXPIRY DATE: (B)(6) 2013; USAGE DATE: (B)(6)2013. REAL AGING TESTS PERFORMED WITH STRYKER IMPLANTS IN 2007 (EQUAL PACKAGING AND STERILIZATION CONDITIONS) REVEAL THAT THERE IS A SAFETY TOLERANCE. IMPLANTS WITH EXCEEDED EXPIRY DATE WERE CHECKED MORE THAN 1 YEAR OVERDUE AND CONSIDERED STILL STERILE SUBSEQUENTLY. THUS, IN THIS SPECIFIC CASE OF EXCEEDED EXPIRY DATE BY 2 MONTHS DAYS A RISK FOR THE PATIENT IS NOT TO BE EXPECTED. NEVERTHELESS, THE EXPIRY DATE OF THE DRILL F. RADIOLUCENT TARGETING DEVICE SHOULD HAVE BEEN NOTICED PRIOR TO SURGERY. THE REPORTED EVENT WAS NOT CAUSED BY A DEFICIENCY IN THE DEVICE. DETERMINATION OF THE ROOT CAUSE THAT THE DEVICE COULD NOT BE LOCATED IN THE CONSIGNED HOSPITAL AND WAS CYCLE COUNTED OUT DOES NOT LIE IN THE RESPONSIBILITY OF THE MANUFACTURER.

    Description of Event or Problem · 1

    A DISPOSABLE DRILL BIT ((B)(4), LOT K913664, EXP 2013-05) WAS USED BY DR DURING THE IMPLANTATION OF A TIBIAL NAIL. NO ONE PRESENT DURING THE CASE NOTICED AND THE CASE WAS COMPLETED.

    Description of Event or Problem · 1

    A DISPOSABLE DRILL BIT (REF (B)(4). LOT K913664. EXP (B)(6) 2013) WAS USED BY DR DURING THE IMPLANTATION OF A TIBIAL NAIL. NO ONE PRESENT DURING THE CASE NOTICED AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463824 DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K913564

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other