BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005180920-2018-00833

    MDR report key: 8008967 · Received October 26, 2018

    Report

    Report Number
    3005180920-2018-00833
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 26, 2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 OCTOBER 2018; IMPACTOR HANDLE: LOT 181436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MARCH 2018. EXPIRATION DATE: 2023-02-20; NO ANOMALIES FOUND RELATED TO THE PROBLEM ON MAT24043: (B)(4) PIECES MANUFACTURER, SECOND EVENT ON THIS MAT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT FEMORAL IMPACTOR/ EXTRACTOR; LOT 181436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MARCH 2018. EXPIRATION DATE: 2023-02-20; NO ANOMALIES FOUND RELATED TO THE PROBLEM ON MAT23070: (B)(4) PIECES MANUFACTURER, FIRST EVENT ON THIS MAT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT PRELIMINARY INVESTIGATION PERFORMED BY R%D PRODUCT MANAGER ON 26 OCTOBER 2018. THE BREAKAGE OF ONE WING OF THE IMPACTOR HANDLE TIP WAS MOST LIKELY CAUSED BY A MISALIGNMENT DURING THE IMPACTION. THE HANDLE IS INTENDED TO BE IMPACTED IN ITS LONG AXIS. IMPROPER IMPACTION DIRECTION CAN OVERLOAD THE CONNECTION WITH A BENDING STRESS WITH THE CONSEQUENT RISK OF BREAKAGE OF THE HANDLE-TIP. DESPITE THIS BREAKAGE IT WAS POSSIBLE TO SUCCESSFULLY END THE SURGERY WITHOUT ANY DELAY. THE REASON OF BREAKAGE OF THE FEMORAL IMPACTOR COULD BE AN EXCESSIVE FORCE APPLIED THROUGH THE HANDLE DURING THE INSTRUMENT TIGHTENING. IN THIS SITUATION THE TWO LATERAL HARMS COULD HAVE BEEN OVER STRESSED REDUCING RESISTANCE DURING IMPACTIONS. ANOTHER FACTOR THAT COULD HAVE CAUSED THE BREAKAGE COULD BE EXCESSIVE LATERAL FORCING TRYING TO REPOSITION IN MEDIO/LATERAL OR FLEXO/RECURVATUM THE FINAL IMPLANT POSITION OR TRYING TO COMPLETE THE IMPLANT POSITIONING USING THIS FEMORAL IMPACTOR EXTRACTOR. THE SURGICAL TECHNIQUE RECOMMENDS TO USE THIS INSTRUMENT ONLY TO POSITION AND CENTERING THE FEMORAL COMPONENT ON THE RESECTED FEMUR BUT TO NOT USE IT FOR FINAL IMPACTIONS. FOR THIS OPERATION THE SURGEON HAS TO USE THE FEMORAL IMPACTOR ASSEMBLED ON THE MULTIFUNCTIONAL HANDLE. HOWEVER, THE ABSENCE OF IMAGES OF THE CASE MAKE DIFFICULT TO BETTER ESTABLISH THE REAL CASE OF THE COMPLAINT.

    Description of Event or Problem · 1

    THE YELLOW TIP FROM THE PLASTIC IMPACTOR HANDLE BROKE DURING USE WHILE SWITCHING TIPS DURING THE PROCEDURE. THE SURGEON WAS ABLE TO FINISH THE CASE USING THE INSTRUMENT TO COMPLETE THE SURGERY. IN ADDITION, WHILE IMPACTING THE FINAL FEMORAL IMPLANT THE IMPACTOR/EXTRACTOR FRACTURED INTO MULTIPLE PIECES.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other