BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 58MM F/IM NAIL-STER

    MDR report key: 6126214 · Received November 23, 2016

    Report

    Report Number
    2520274-2016-15497
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THE SUBJECT DEVICE WAS REPORTEDLY DISCARDED BY THE REPORTING FACILITY. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. 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 THAT A PROXIMAL INTERLOCK SCREW DEFLECTED POSTERIOR TO A NAIL DURING AN INTRAMEDULLARY (IM) NAILING OF THE RIGHT FEMUR ON (B)(6) 2016. A NEW HOLE WAS DRILLED INTO THE NAIL, THE PROXIMAL INTERLOCK SCREW WAS TAKEN OUT AND A NEW SCREW WAS FREEHANDED (MANUALLY SCREWED) INTO THE NAIL. THERE WAS A REPORTED FIFTEEN (15) MINUTE SURGICAL DELAY AND ADDITIONAL X-RAYS WERE REQUIRED. THE FINAL CONSTRUCT CONSISTED OF ONE IM FEMORAL NAIL AND FOUR SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 11MM X 400MM RETROGRADE/ANTEGRADE FEMORAL NAIL (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1), PERCUTANEOUS INSERTION HANDLE (PART #03.010.046, LOT #1403145, QUANTITY 1), AIMING ARM (PART #03.010.049, LOT #4997216, QUANTITY 1), TROCAR (PART #03.010.070, LOT #5150423, QUANTITY 1), PROTECTION SLEEVE (PART #03.010.063, LOT #1412961, QUANTITY 1), DRILL SLEEVE (PART #03.010.065, LOT #4765006, QUANTITY 1), CANNULATED CONNECTING SCREW (PART #03.010.146, LOT #U139901, QUANTITY 1), T25 IM NAIL SCREWDRIVER (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775222 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 58MM F/IM NAIL-STER SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 03.010.046, LOT 1403145, PERCUTANEOUS INSERTION HA| 03.010.049, LOT 4997216, AIMING ARM FOR ANTEGRADE| 03.010.063, LOT 1412961, 12.0MM/8.0MM PRO SLEEVE| 03.010.065, 4765006, 8.0MM/4.2MM DRILL SLEEVE| 03.010.070, LOT 5150423, 4.2MM TROCA 210MM| 03.010.146, LOT U139901, CANN CONNECT SCREW| UNKNOWN 11MMX400MM RETROGRADE/ANTEGRADE FEM NAIL| UNKNOWN T25 IM NAIL SCREWDRIVER