BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE CLAMP SERR 180MM

    MDR report key: 8744450 · Received June 28, 2019

    Report

    Report Number
    9610612-2019-00440
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 28, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: THE INSTRUMENT IS NOT AVAILABLE FOR INVESTIGATION. BATCH HISTORY REVIEW: THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE: NO PRODUCT AVAILABLE AND THEREFORE IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE. IT APPEARS THAT THE CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST LIKELY USAGE RELATED. RATIONALE: ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT CAUSE. THERE IS THE POSSIBILITY FOR A USAGE ERROR DUE TO IMPROPER HANDLING OR MECHANICAL OVERLOAD SITUATION. IF FURTHER INVESTIGATIONS ARE REQUIRED, THE PRODUCT SHOULD BE PROVIDED FOR EXAMINATION.

    Description of Event or Problem · 0

    PER SUS VOLUNTARY EVENT FORM MW5086909, RECEIVED BY THE FDA, THERE WAS AN INSTRUMENT MALFUNCTION. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LEWIN BONE CLAMP. DURING A KNEE ARTHROPLASTY PROCEDURE, THE BONE CLAMP WAS USED TO ATTEMPT TO GRASP THE FEMORAL HEAD. ONE SIDE OF THE INSTRUMENT BROKE OFF AT THAT TIME; NEXT, THE HANDLE AND PIECE WERE RETRIEVED AND THE PARTS WERE MATCHED-UP TO ENSURE THAT NOTHING REMAINED WITHIN THE STERILE FIELD. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. FURTHER INFORMATION WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538448 LEWIN BONE CLAMP SERR 180MM BASIC INSTRUMENTS HTD AESCULAP AG MD455

    Patients

    Seq Age Sex Outcome Treatment
    1