BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECTANGULAR BONE CURETTE

    MDR report key: 2883355 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01641
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS FAILURE OCCURRED DUE TO BENDING STRESS BEYOND THE ULTIMATE STRENGTH OF THE MATERIAL. IF THE DISTAL TIP WERE COMPLETELY CONSTRAINED, 22 POUNDS APPLIED TO THE HANDLE WOULD POTENTIALLY BREAK THE CURETTE. CONSIDERING THESE BOUNDARY CONDITIONS ARE NEARLY CLINICALLY IMPOSSIBLE, THE STRENGTH FOR THIS INSTRUMENT UNDER NORMAL USE IS ACCEPTABLE. RELEASED IN 1999, THIS IS A MATURE RECTANGULAR BONE CURETTE. THE DRAWINGS CALL OUT APPROPRIATE MATERIALS AND DIMENSIONS FOR ROBUST CURETTE DESIGN. AN EXACT CAUSE FOR THIS COMPLAINT IS NOT POSSIBLE DUE TO UNKNOWN CLINICAL BOUNDARY CONDITIONS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT FOR DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE DEVICE HISTORY RECORD IS NOT AVAILABLE FOR REVIEW AS THE DEVICE IS OVER TWELVE YEARS OLD.

    Description of Event or Problem · 1

    POSTERIOR LUMBAR FUSION L5-S1, DURING DISCECTOMY TOP OF BOX CURETTE BROKE OFF INTO THE SURGICAL SITE. ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECTANGULAR BONE CURETTE BONE CURETTE FZS SYNTHES GMBH A7JA22

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR