BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3162543 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02909
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE INSTRUMENT WAS USED FOR A SURGERY ON THE (B)(6) 2013 BECAUSE OF A PROXIMAL FEMORAL FRACTURE. THE DHS BLADE COULD NOT BE LOCKED BY THE HEAD OF THE SCREWDRIVER T15 (ART. 03.224.004). THE TIP OF THE INSTRUMENT MAY REMAIN INSIDE OF THE DHS BLADE IN THE PATIENT BODY. ANOTHER INSTRUMENT WAS TESTED UNDER LABORATORY CONDITIONS AND USED AS A REFERENCE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE BREAKAGE OF THE INSTRUMENT IS COMPARABLE WITH THE BREAKAGE OF THE TEST INSTRUMENT WHICH WAS BROKEN UNDER LABORATORY CONDITIONS. ALL INSTRUMENTS WERE SUBJECTED TO HIGH DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE INSTRUMENTS. THE INSTRUMENTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH PROXIMAL FEMUR FRACTURE. REPORTEDLY DURING THE PROCEDURE ON (B)(6) 2013, THE DHS BLADE COULD NOT BE LOCKED BY THE HEAD OF THE T15 STARDRIVE SCREWDRIVER SHAFT (03.224.004). THE SURGEON COULD NOT IDENTIFY THE CAUSE; WHETHER THE SCREWDRIVER HEAD NOT REACHING THE END OF TIGHT-FIT OR A MALFUNCTION OF THE DHS BLADE IS PREVENTING THE LOCK. THE SURGEON COULD NOT LOCK BY SPINNING FREELY. IT WAS REPORTED THE TIP OF THE CONNECTING SCREW WAS BROKEN WHEN IT WAS RETURNED. IT IS POSSIBLE THAT THE TIP OF THE CONNECTING SCREW IS STUCK INSIDE OF THE DHS BLADE, SUBSEQUENTLY CAUSING A BAD CONNECTION OF THE SCREWDRIVER. THE TIP OF THE CONNECTING SCREW MAY HAVE REMAINED INSIDE OF THE DHS BLADE IMPLANTED IN THE PATIENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263383 CONNECSCR F/INSERTION DHS BLADE LXH SYNTHES GMBH 2290282

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR