BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT REDUCTION CLAMP

    MDR report key: 4131295 · Received October 1, 2014

    Report

    Report Number
    0008031020-2014-00456
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE POINTS DEFORM AND BREAK OFF FOR STRAIGHT REDUCTION CLAMP COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE ZAEHNE SPITZ BENDING WAS ATTRIBUTED TO A USER RELATED ISSUE. IN REGARD OF THE RESULTS ON BML 12-169: VARIAX CLAVICLE REDUCTION CLAMP: CORROSION AND CYCLIC STRENGTH TEST [2] AND MEMO V12073_500: VARIAX CLAVICLE CLAMP AND FORCEPS: CYCLIC STRENGTH TEST [3]. WE CAN CONCLUDE THAT THE ROOT CAUSE OF THE FAILURE MODE REF#703822 STRAIGHT REDUCTION CLAMP - ZAEHNE SPITZ BENDING (TIP BENDING) IS DUE TO ¿USER RELATED¿. THE STRAIGHT REDUCTION CLAMP SHALL BE USE ONLY ON BONE MATERIAL. IN THE EVENT OF A USE IN A MATERIAL WITH A YIELD STRENGTH SUPERIOR AS THE BONE THE FAILURE MODE ZAEHNE SPITZ BENDING COULD OCCUR. [2] MEMO V12073_500: VARIAX CLAVICLE CLAMP AND FORCEPS: CYCLIC STRENGTH TEST [3] BML 12-169: VARIAX CLAVICLE REDUCTION CLAMP: CORROSION AND CYCLIC STRENGTH TEST A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE, THAT THE LOBSTER CLAMP DOES NOT CLOSE UNDER TENSION OF A REDUCTION. THE WEBER CLAMP POINTS DEFORM AND BREAK OFF DURING BONE REDUCTION.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE, THAT THE LOBSTER CLAMP DOES NOT CLOSE UNDER TENSION OF A REDUCTION. THE WEBER CLAMP POINTS DEFORM AND BREAK OFF DURING BONE REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611876 STRAIGHT REDUCTION CLAMP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH R37871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other