BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 115MM

    MDR report key: 4513366 · Received February 12, 2015

    Report

    Report Number
    3003506883-2015-10036
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 1, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 NARRATIVE: PRODUCT INVESTIGATION EVALUATION: ONE INSERTION HANDLE (PART 357.411 / LOT 4826269), ONE 130° AIMING ARM (PART 357.366 / LOT 4846962), ONE HELICAL BLADE (PART 456.308 / LOT 7505242), AND ONE TROCHANTERIC FIXATION NAIL (PART 456.322 / LOT 7885085) WERE RETURNED WITH THE COMPLAINT THAT ¿DURING A TROCHANTERIC NAIL FIXATION (TFN) PROCEDURE THERE WAS AN ISSUE WITH THE HELICAL BLADE AND THE NAIL INTERLOCKING. THE NAIL AND BLADE WERE REMOVED AND A SECOND NAIL AND BLADE WERE IMPLANTED. THE SAME INSERTION HANDLE AND AIMING ARM WERE SUCCESSFULLY USED TO INSERT THE NEW NAIL AND BLADE.¿ UPON RECEIPT OF THESE DEVICES, THE TFN IS DAMAGED AT THE LATERAL SIDE OF THE HELICAL BLADE CUT OUT. THE HELICAL BLADE IS DAMAGED AT THE DISTAL TIP WITH MATERIAL MISSING, LIKELY DUE TO THESE TWO IMPLANTS CONTACTING EACH OTHER AT THESE AREAS. ALSO, THE PROXIMAL LOCKING MECHANISM OF THE TFN WAS NOT ENGAGED. THE COMPLAINT CONCERNING THESE IMPLANTS IS CONFIRMED. WHEN THE AIMING ARM AND INSERTION HANDLE WERE ASSEMBLED AND ATTACHED TO THE TFN, THE ALIGNMENT WAS ADEQUATE FOR PROPER INSERTION OF THE HELICAL BLADE THROUGH THE CUTOUT IN THE TFN. THE DRAWINGS FOR THE HELICAL BLADE WERE REVIEWED, NO DIMENSIONAL DISCREPANCIES WERE IDENTIFIED AND THE DESIGN OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE. THIS COMPLAINT CONDITION IS LIKELY A RESULT OF IMPROPER ASSEMBLY OF THE SYSTEM PRIOR TO HELICAL BLADE INSERTION, WHICH WOULD LEAD TO MISALIGNMENT. THE DESIGNS OF THESE DEVICES ARE ADEQUATE FOR THEIR INTENDED USES AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT DURING A TROCHANTERIC NAIL FIXATION PROCEDURE THERE WAS AN ISSUE WITH THE HELICAL BLADE AND THE NAIL INTERLOCKING. THE NAIL AND BLADE WERE REMOVED AND A SECOND NAIL AND BLADE WERE IMPLANTED. THE SAME INSERTION HANDLE AND AIMING ARM WERE SUCCESSFULLY USED TO INSERT THE NEW NAIL AND BLADE. THERE WAS A REPORT OF A ONE HOUR DELAY IN SURGERY. THIS REPORT IS 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106167 11.0MM TI HELICAL BLADE 115MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 7505242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention