BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010

    MDR report key: 6696809 · Received July 10, 2017

    Report

    Report Number
    8030965-2017-13448
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    May 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE 510K NUMBER WAS REPORTED AS K971544 IN THE INITIAL MEDWATCH, THE 510K IS EXEMPT. REPORTER NUMBER REPORTED AS UNKNOWN IN THE INITIAL MEDWATCH, THE REPORTER NUMBER IS (B)(6). 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

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED OSTEOTOMY SURGICAL PROCEDURE OF THE FOOT, IT WAS OBSERVED THAT THE QUICK COUPLING FOR K WIRES DEVICE DID NOT WORK. ACCORDING TO THE REPORTER, IT WAS NOTED THAT THE DEVICE DID NOT FIT RIGHT INTO THE SMALL BATTERY DRIVE DEVICE PERFORATOR AND WOULD NOT FIT WITH THE PERIOSTEAL ELEVATOR WHICH THE SLIGHTLY CURVED BLADE AND ROUGH EDGE BROKE DURING USE. IT WAS REPORTED THAT THE BROKEN PIECES WERE ALL RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS AN UNSPECIFIED AMOUNT OF DELAY TO THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479289 QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010 INSTR, SURGICA, ORTHOPEDIC, AC-POWERED MOTRO/ACCESS & ATTACH HWE SYNTHES OBERDORF N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 BLADE DEVICE.| SMALL BATTERY DRIVE DEVICE.