BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,NAIL

    MDR report key: 6013781 · Received October 10, 2016

    Report

    Report Number
    9612488-2016-10413
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE UNKNOWN SCREW. IT IS UNKNOWN WHICH ONE OF THESE TWO SCREWS WAS THE REASON. LOCKSCR Ø5 SELF-TAP L46 TAN / PART # 413.346S / LOT: 9251161 / QUANTITY 1. (B)(4). LOCKSCR Ø5 SELF-TAP L50 TAN / PART # 413.350S / LOT: 9157774 / QUANTITY 1. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4) X-RAY TAKEN. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 413.346S, LOT # 9251161. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: NOV 25, 2014. EXPIRY DATE: NOV 01, 2024, ARTICLE WAS STERILIZED BY SUPPLIER (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING THE MANUFACTURING OF THIS PRODUCT THAT CONTRIBUTED TO THIS COMPLAINT CONDITION. THE 510(K): K000682. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 413.350S, LOT # 9157774. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 02, 2014. EXPIRY DATE: SEP 01, 2024, ARTICLE WAS STERILIZED BY SUPPLIER (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING THE MANUFACTURING OF THIS PRODUCT THAT CONTRIBUTED TO THIS COMPLAINT CONDITION. THE 510(K): K023941. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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 (B)(4) REPORTED AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016 PATIENT UNDERWENT SURGERY FOR REMOVING LCP-PLT (LOCKING COMPRESSION PLATE). DURING THE SURGERY, THE LOCKING SCREW OF THE SECOND PROXIMAL HOLE COULD NOT BE REMOVED BY USING THE STANDARD SCREWDRIVER BECAUSE IT WAS FIXED FIRMLY. THUS EXTRACTION SCREW WAS USED TO REMOVE THE SCREW. AT FIRST, THE LOCKING SCREW COULD NOT BE ATTACHED TO EXTRACTION SCREW, SO THE SURGEON SCRAPED THE HEAD OF THE LOCKING SCREW AND TRIED ONCE AGAIN. DURING THE SECOND ATTEMPT, THE TIP OF EXTRACTION SCREW WAS BROKEN AND THE BROKEN PART REMAINED IN THE LOCKING SCREW. CARBIDE DRILL WAS USED TO SCRAPE THE SCREW HEAD, HOWEVER IT DID NOT WORK. THE SURGEON THEN USED A DIAMOND BAR (OWNED BY THE HOSPITAL) TO DRILL THE PLATE AND THE SCREW HEAD OFF. THE SCREW SHAFT WAS REMOVED BY A PAIR OF PLIERS AND THE INCISION WAS CLOSED AFTER REMOVING THE REMAINING METAL DEBRIS AS MUCH AS POSSIBLE. SIXTY (60) MINUTES DELAY IN REMOVAL SURGERY WAS REPORTED. PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2016 FOR ORIF (OPEN REDUCTION AND INTERNAL FIXATION) FOR MULTIPLE TRAUMAS. FRACTURE OF RIGHT PROXIMAL TIBIA, SHAFT OF RIGHT TIBIA, RIGHT MEDIAL MALLEOLUS, LATERAL MALLEOLUS, ETC. LCP-PLT (RIGHT 13 HOLES) WAS USED TO FIX THE TIBIA. SURGEON'S COMMENT: AFTER THE PLATE HAD BEEN REMOVED, THE SHAFT COULD BE EASILY TAKEN OFF BY USING A PAIR OF PLIERS, SO THE CAUSE MIGHT BE THE PLATE AND THE SCREW TIGHTLY FIXED TOGETHER. THE PRIMARY SURGERY WAS SEVEN (7) MONTHS AGO AND THE SCREW HAD NOT BEEN PLACED FOR A LONG PERIOD. THE POSITION OF THE SCREW WAS PROPER ACCORDING TO THE X-RAY. CONCOMITANT DEVICES: ONE (1) UNKNOWN CARBIDE DRILL, ONE (1) UNKNOWN DIAMOND BAR, ONE (1) UNKNOWN PAIR OF PLIERS. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666324 APPLIANCE,FIXATION,NAIL KTT SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention ONE (1) UNKNOWN CARBIDE DRILL| ONE (1) UNKNOWN DIAMOND BAR| ONE (1) UNKNOWN PAIR OF PLIERS