BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 6841906 · Received September 5, 2017

    Report

    Report Number
    3009450884-2017-10125
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 14, 2017
    Report Date
    August 14, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    KTT
    PMA / PMN Number
    K023941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL 510K#: K000682 DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 05.OCT.2016 EXPIRY DATE: 01.SEP.2026. 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. AS IT WAS REPORTED THAT THE HEAD PART OF THE SCREW WAS BROKEN AND THE SURGEON COULD NOT REMOVE IT. THE SCREW WAS REMAINING IN THE PATIENT. PLEASE DO PROVIDE A STATEMENT REGARDING THE MATERIAL. THE DHR REVIEW FOR THE WORK ORDER (B)(4)/ PART NUMBER 413.370S SHOWED THAT THERE WERE NO NCS RAISED DURING THE MANUFACTURING OF THIS LOT NEITHER SCRAP DOCUMENTED. AS WELL AS, ITS MATERIAL CERTIFICATE WITH CHARGE NUMBER (B)(4) SHOWS THAT THE RAW MATERIAL USED TO MANUFACTURE THE LOT IN QUESTION IT IS ACCORDING TO ITS SPECIFICATIONS. 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 THE SURGERY FOR THE FRACTURE OF LEFT FEMUR WAS PERFORMED ON (B)(6) 2017. DURING THE SURGERY, A LOCKING SCREW WAS INSERTED INTO THE PLATE AND THE POSITION OF IT WAS CONFIRMED BY X-RAY. THE PLATE WAS SET BACKWARD, SO THAT THE SURGEON TRIED TO REMOVE THE SCREW. AT THAT TIME, HEAD PART OF THE SCREW WAS BROKEN AND THE SURGEON COULD NOT REMOVE IT. THE SCREW WAS REMAINING IN THE PATIENT AND THE SURGERY WAS FINISHED. THE SURGERY WAS COMPLETED WITH A 10-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO OTHER MEDICAL INTERVENTION REQUIRED. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICE: 1X UNK PLATE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623143 2.5MM DRILL BIT/QC/GOLD/110MM APPLIANCE,FIXATION,NAIL KTT SYNTHES GRENCHEN L149221

    Patients

    Seq Age Sex Outcome Treatment
    1