BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 6073714 · Received November 2, 2016

    Report

    Report Number
    9612488-2016-10444
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 6, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: PART: 03.010.407, LOT: 9052175, MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 03 SEPTEMBER 2014 . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DISTAL LOCKING OF A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) THROUGH THE INSERTION HANDLE, THE SURGEON DID NOT HIT THE SCREW HOLE WITH THE DRILL BIT. THE AIMING AND INSERTION DEVICES AIMED POSTERIORLY OF THE DISTAL SCREW HOLE FROM THE PFNA. THE SURGERY TOOK PLACE ON (B)(6) 2016. THE ISSUE PROLONGED THE PROCEDURE BY 30 MINUTES. THE NAIL AND THE BLADE WERE EVENTUALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FREEHAND LOCKING OF 240 MM NAIL. THE SUBSTITUTE AIMING ARM AND INSERTION HANDLE WERE NOT USED. COMPLAINT INVOLVES 2 PARTS. REPORTED CONCOMITANT DEVICES: PFNA NAIL (PART: 472.265S, LOT: 9962368, QUANTITY: 1). DRILL BIT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS 2 OF 2 OF COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725218 AIM-ARM 130° F/PFNA BLADE GUIDE FZX SYNTHES BETTLACH 9052175

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 472.265S,PFNA NAIL LOT: 9962368, QUANTITY: 1| DRILL BIT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: