BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.9MM TI LOCKING BOLT 34MM

    MDR report key: 6617875 · Received June 7, 2017

    Report

    Report Number
    3009417901-2017-10018
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 9, 2017
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    UDI-DI
    07611819702523
    PMA / PMN Number
    K970733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 5939921. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 07.SEP.2016. EXPIRATION DATE: 01.AUG.2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OR STERILIZATION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OR STERILIZATION OF THE SUBJECT DEVICE. 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

    ADDITIONAL PRODUCT CODES: HTY, JDW, JDS, JDN. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE FOR A DISTAL FEMORAL FRACTURE ON (B)(6) 2017. THE DISTAL FEMORAL NAIL (DFN) WAS FIXED BY THE LOCKING BOLTS. SURGEON ATTEMPTED TO REMOVE ONE OF THE LOCKING BOLTS WITH THE HEXAGONAL SCREWDRIVER BUT THE TIP OF THE SCREWDRIVER SLIPPED OUT OF THE HEAD OF THE LOCKING BOLT. SURGEON WAS ABLE TO REMOVE ONE OF THE LOCKING BOLTS UTILIZING ROUND-NOSED PLIERS. THIS LOCKING BOLT WAS REPLACED WITH ANOTHER LOCKING BOLT THAT WAS 2MM SHORTER IN LENGTH. THE OTHER LOCKING BOLT WAS COMPLETELY STRIPPED AND COULD NOT BE REMOVED, PREVENTING SURGEON FROM INSERTING ANYTHING INTO THAT PLATE HOLE. IT WAS REPORTED THERE WAS POTENTIALLY A THIRD LOCKING BOLT THAT WAS ALSO DIFFICULT TO REMOVE. PROCEDURE WAS DELAYED APPROXIMATELY 20 MINUTES. CONCOMITANT DEVICES REPORTED: DISTAL FEMORAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SCREWDRIVER (314.750, LOT 5000213, QUANTITY 1), REMOVAL TOOL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING BOLT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400280 4.9MM TI LOCKING BOLT 34MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SALZBURG 5939921 07611819702523

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE (PART AND LOT UNKNOWN, QTY 1)| REMOVAL TOOL (PART AND LOT UNKNOWN, QTY 1)| SCREWDRIVER (314.750, LOT 5000213, QTY 1)