BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS BLADE Ø12.5 L75 TAN

    MDR report key: 3072552 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01866
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED DHS BLADE SHOWS FULL CONFORMITY TO THE SPECIFICATIONS. CARRIED OUT FUNCTIONAL TESTS COULD NOT REPRODUCE THE REPORTED PROBLEM. IT WAS EASY TO CONNECT THE BLADE WITH THE IMPACTOR AS FORESEEN. VISIBLE SIGNS AT THE IN-HEX LED US ASSUME THAT THE BLADE WAS NOT IN CORRECT ALIGNMENT TO THE IMPACTOR WHILE CONNECTING PROCEDURE. NO PRODUCT FAULT COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6)AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 WITH A PATIENT PRESENTED WITH A FEMORAL NECK FRACTURE, IT WAS REPORTED THE DHS BLADE DISENGAGED FROM THE IMPACTOR FOR PFNA BLADE INSTRUMENT DURING THE INSERTION OF THE BLADE ACCORDING TO THE OPERATIVE PROCEDURE. REPORTEDLY THE DOCTOR TRIED TO IMPLANT THE PLATE AS IT WAS HOWEVER IT WAS HARD TO TAKE THE SAME DIRECTION AND HE COULD NOT IMPLANT IT. HE THEN TRIED TO REMOVE THE PLATE AND RE-IMPLANT IT BUT WAS UNSUCCESSFUL. THE DOCTOR SELECTED ANOTHER PLATE THAT WAS ONE SIZE SMALLER AND COMPLETED THE IMPLANTATION WITHOUT ANY PROBLEM. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175486 DHS BLADE Ø12.5 L75 TAN HSB SYNTHES GMBH 8201448

    Patients

    Seq Age Sex Outcome Treatment
    1