BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM

    MDR report key: 3091581 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02097
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATIONS FOUND THAT THE DHS/DCS GUIDE WIRE BECAME DAMAGED DUE TO STRONG CONTACT WITH THE REAMER. WE HAVE TO ASSUME THAT THE GUIDE WIRE WAS SLIGHTLY BENT DURING REAMING AND THEREFORE CAME INTO CONTACT WITH THE REAMER DURING DRILLING. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON PERFORMED A SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. AFTER INSERTION OF THE DHS GUIDE WIRE, THE SURGEON TRIED TO REAM FOR A LAG. THE SECOND REAMER COULDN'T BE PUSHED FROM THE LATERAL CORTICAL BONE AREA. THE SURGEON CONSIDERED THE CORTICAL BONE TO BE HARD AND TRIED TO MOVE THE REAMER BACKWARD AND FORWARD WITH A ROTATION THREE TIMES. THE SURGEON CHECKED AN X-RAY IMAGE. THE SURGEON FOUND SOME ARTIFACTS 50 MM FROM THE DISTAL END OF THE GUIDE WIRE. THE SURGEON WAS UNABLE TO CATCH IT USING FORCEPS. THE SURGEON TRIED TO REAM AGAIN AND FOUND THE PENETRATION OF THE GUIDE WIRE INTO THE BONE HEAD USING THE X-RAY IMAGE. NO IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193715 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 7726646

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR