BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3605356 · Received February 4, 2014

    Report

    Report Number
    8030965-2014-00212
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 12, 2014
    Report Date
    January 12, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4): ACCORDING TO THE ADDITIONAL EVALUATION, THE INSERTION HANDLE WAS RECEIVED IS IN A WORN-OUT CONDITION; SEVERAL HITTING MARKS AND SCRATCHES ARE OBSERVABLE ON THE SURFACE. OBVIOUS EVIDENCE OF SEVERAL HAMMER BLOWS IS VISIBLE ON THE COMPLAINED SURFACE. THE EDGE OF DRILLED HOLE IS DEFORMED DUE TO AT LEAST THREE HITS WITHIN A 1 CM AREA. WHEN PLUGGING THE PROTECTION SLEEVE, IT STICKS EXACTLY WHERE THESE HITTING MARKS ARE. SEVERAL MORE HAMMER BLOW TRACES ARE VISIBLE ON THE DEVICE SURFACE. DEVICE HISTORY RECORD REVIEW SHOWS NO SIGNS OF MATERIAL PROBLEM OR PRODUCT NONCONFORMITY. NO PRODUCT FAULT DETECTED. ALL THE LISTED FACTS INDICATE MISUSE SO WE CONSIDER THIS COMPLAINT AS INVALID.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRODUCT DEVELOPMENT EVENT EVALUATION STATED: THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE HAMMERING OF THE INSERTION HANDLE¿S DISTAL SLEEVE GUIDE HOLE WAS RESPONSIBLE FOR THIS COMPLAINT AND DETERMINED AS NOT THE RESULT OF A DESIGN DEFICIENCY. PARTS 03.010.045 AND 03.010.063 ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AS RECOMMENDED. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LATERAL ENTRY FEMORAL NAIL (LEFN) PROCEDURE, THE SURGEON HAD A PROBLEM WITH TWO OF THE LATERAL ENTRY FEMORAL NAIL INSTRUMENTS. WHEN INSERTING PART NUMBER/LOT NUMBER 03.010.063/4933987 (12.0MM/8.0MM PROTECTION SLEEVE 188MM) IT WOULD NOT GO THROUGH PART NUMBER/LOT NUMBER 03.010.045/1768650 (STANDARD INSERTION HANDLE). A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) SET WAS AVAILABLE, BUT THE SURGEON WAS UNABLE TO INSERT AN OBLIQUE LOCKING SCREW AND A SECOND PROBLEM OCCURRED WITH THE SAME 03.010.043 TROCAR. WHEN THE SCREW WENT THROUGH THE TROCAR, IT WAS UNABLE TO EXIT THE SIDE CLOSEST TO THE BONES. THE SURGEON HAD TO REMOVE THE SCREW AND USE THE SCREW FROM THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) SET TO SUCCESSFULLY INSERT THE SCREW. THE SURGERY WAS PROLONGED 15 MINUTES. NO FURTHER INFORMATION WAS PROVIDED. PATIENT STATUS/OUTCOME FOLLOWING THE PROCEDURE WAS NOT PROVIDED. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71560 STANDARD INSERTION HANDLE LXH SYNTHES GMBH 1768650

    Patients

    Seq Age Sex Outcome Treatment
    1