BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOFIL CRCLG TENSION/CRIMPER

    MDR report key: 3165789 · Received June 12, 2013

    Report

    Report Number
    0001825034-2013-01925
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EVALUATION OF PRODUCT INDICATES FRACTURE IS DUE TO THE AGE OF THE PRODUCT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FROM PROLONGED USE, AND THROUGH MISUSE OR ROUGH HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE. TO MINIMIZE DAMAGE, THE FOLLOWING SHOULD BE DONE: INSPECT THE INSTRUMENT CASE AND INSTRUMENTS FOR DAMAGE WHEN PURCHASED AND AFTER EACH USE AND CLEANING. INCOMPLETELY CLEANED INSTRUMENTS SHOULD BE RE-CLEANED, AND THOSE THAT NEED REPAIR SET ASIDE FOR REPAIR SERVICE OR RETURN TO BIOMET."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2013 UTILIZING A TENSIONER-CRIMPER TROCHANTERIC GRIP. WHILE THE SURGEON WAS SECURING THE CABLE, THE CRIMPER FRACTURED. THE FRACTURED PIECES WERE RETRIEVED FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266228 MONOFIL CRCLG TENSION/CRIMPER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXQ BIOMET ORTHOPEDICS N/A 14884

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R