BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SPIRAL BLADE 100MM

    MDR report key: 2820753 · Received November 6, 2012

    Report

    Report Number
    3003506883-2012-00350
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K6528687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI SPIRAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS CONDUCTED. THE PART RECEIVED WAS DAMAGED. APPROXIMATELY 44MM OF THE TIP IS MISSING. THE REMAINING PORTION EXHIBITS MODERATE SCUFFING AND AREAS OF MISSING ANODIZE COLOR. THE EDGE OF THE BREAK SHOWS DEFORMATION THAT APPEARS AS IF THE BLADE WAS BENT OR TWISTED UNTIL IT SNAPPED. BECAUSE A SIGNIFICANT PORTION OF THE PART IS MISSING, THERE IS NO POSSIBILITY OF ACCURATELY MEASURING THIS PIECE. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. A REVIEW OF THE PRODUCT DRAWINGS AND COMPLAINT HISTORY SHOW THAT THE DESIGN IS ADEQUATE FOR THE INTENDED USE. ADDITIONALLY, THE RISK ASSESSMENT APPROPRIATELY ADDRESSES THIS EVENT. TWO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT ARE THE DAMAGE SUSTAINED TO THE BLADE DURING INSERTION (EVIDENT ON BOTH THE BLADE AND LOCKING SLEEVE) AND THE OFF-INDICATION USE OF THIS IMPLANT. ACCORDING TO THE TECHNIQUE GUIDE, THE SPIRAL BLADE IS ONLY INDICATED FOR SUBTROCHANTERIC FRACTURES. THE X-RAYS PROVIDED INDICATE THE PRODUCT WAS USED FOR A TRANSVERSE INTERTROCHANTERIC FRACTURE. THE IMPLANT APPEARS TO HAVE BEEN USED OFF-INDICATION, AS WELL AS DAMAGED DURING INSERTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A HARDWARE REMOVAL PROCEDURE. THE PATIENT WAS IMPLANTED WITH A TITANIUM FEMORAL NAIL WITH SPIRAL BLADE ON (B)(6) 2012. POST-OPERATIVELY, THE PATIENT PRESENTED TO THE SURGEON WITH PAIN AND LIMITED MOBILITY. X-RAY REVEALED PART OF THE BLADE HAD BROKEN OFF CAUSING THE FEMORAL NECK TO COLLAPSE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. A BROKEN PORTION OF THE BLADE IS LODGED IN THE FEMORAL HEAD AND COULD NOT BE REMOVED. THE PATIENT WAS REVISED TO HEMI-HIP ARTHROPLASTY. THIS IS REPORT #1 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI SPIRAL BLADE 100MM SPIRAL BLADE HSB SYNTHES ELMIRA 6528687

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention