BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L95 TAN

    MDR report key: 2954693 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00366
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 12, 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRESENT IMPACTOR WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE RESPONSIBLE PRODUCT MANAGER FOUND NO DAMAGE REGARDING THE FUNCTION OF THE INPACTOR. NOTE THAT THIS INSTRUMENT WAS SOLD IN 2008 AND IT SHOWS A WORN HANDLE THAT IT HAS BEEN HEAVILY USED. THE PFNA-II BLADE WAS EXAMINED BY THE PRODUCT MANAGER AS WELL, HERE THE FEEDBACK; THE BLADE IS BLOCKED DUE TWISTING OF THE HULL AND BLOCKED ON THE IMPACTOR. AFTER DISMANTLING THE FUNCTION WAS WORKING OKAY. THE HEXAGONAL DRIVE IS DAMAGED AND THE SCREW IS BROKEN. NO PRODUCT FAULT CAN BE FOUND FOR BOTH PRODUCTS. PRODUCT IS A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN OPERATION FOR FIXATION OF SUBTROCHANTERIC FRACTURE, THE PFNA-II BLADE AND IMPACTOR F/PFNA BLADE WOULD NOT LOCK AND TURN PROPERLY. IT WAS REPORTED THE DOCTOR COMPLETED THE FIXATION USING A PFNA LONG BLADE FOLLOWING THE REMOVAL OF THE CANNULATED CANCELLOUS HIP SCREW. FOLLOWING THE INSERTION OF THE PFNA LONG BLADE THE NURSE ATTACHED THE PFNA II BLADE TO AN IMPACTOR F/PFNA BLADE. IT WAS UNCERTAIN IF THE NURSE/DOCTOR PERFORMED THE OPERATION CHECK FOR THE BLADE PRIOR TO USE. THE DOCTOR INSERTED THE BLADE TOO FAR. AS A RESULT, HE WITHDREW THE BLADE A LITTLE HOLDING THE IMPACTOR WITH PLIERS WHILE KNOCKING THE PLIERS WITH A HAMMER. THE DOCTOR THEN TRIED TO LOCK THE BLADE BUT THE IMPACTOR WOULD NOT MOVE CLOCKWISE AND/OR COUNTER CLOCKWISE. HE THEN REMOVED THE BLADE AND NOTED THE BLADE WAS NOT LOCKED AND/OR TURNED. THE BLADE WAS ALSO NOT SEPARATED FROM THE IMPACTOR. THE DOCTOR INSERTED A DIFFERENT SIZE BLADE USING ANOTHER DEVICE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59314 PFNA-II BLADE L95 TAN BLADE HWC SYNTHES GMBH 8071953

    Patients

    Seq Age Sex Outcome Treatment
    1