BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 125° F/PFNA BLADE

    MDR report key: 6167990 · Received December 12, 2016

    Report

    Report Number
    9612488-2016-10503
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 17, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    UDI-DI
    07611819349438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE/AIM-ARM 125° F/PFNA BLADE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE 510K#: UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART 03.010.406 / 9633962; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 21ST SEPTEMBER 2015; LOT OF (B)(4) PIECES WAS RELEASED BASED ON STEP 0070 OF WORK ORDER (B)(4). NEITHER DEVIATION NOR ANY NCRS WERE MARKED IN THIS DOCUMENT. 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 SURGERY ON (B)(6) 2016 FOR FEMUR TROCHANTERIC FRACTURE THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON CHECKED THE DEVICES BEFORE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 1 MINUTE. NO INFORMATION ABOUT PATIENT CONDITION AND OUTCOME AVAILABLE. THIS COMPLAINT INVOLVES 3 PARTS. CONCOMITANT REPORTED PARTS: 1X PROTECTION SLEEVE (PART 356.818 LOT 8083906); 1X BUTTRESS COMPRESSION NUT (PART 356.817 LOT 8163286). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817381 AIM-ARM 125° F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES BETTLACH 9633962 07611819349438

    Patients

    Seq Age Sex Outcome Treatment
    1 356.817 LOT 8163286,1X BUTTRESS COMPRESSION NUT| 356.818 LOT 8083906, 1X PROTECTION SLEEVE