BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 3954148 · Received July 23, 2014

    Report

    Report Number
    3003506883-2014-10078
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 26, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7503517 OF 11.0MM TI HELICAL 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE 456.305 11.0MM TITANIUM HELICAL BLADE, 456.322 170MM TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, AND 458.940 5.0MM TITANIUM LOCKING SCREW ARE IMPLANTS ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM (TECHNIQUE GUIDE (B)(4)). THE RETURNED 456.322 170MM TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SHOWS MODERATE WEAR AND DISCOLORATION CONSISTENT WITH IMPLANTATION AND REMOVAL. DRAWING (B)(4) WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. NO PRODUCT ISSUE WAS IDENTIFIED IN THE COMPLAINT DESCRIPTION OR NOTED UPON EXAMINATION. THEREFORE, A REVIEW OF THE RISK ASSESSMENT IS NOT APPLICABLE FOR THIS DEVICE. THE RETURNED 458.940 5.0MM TITANIUM LOCKING SCREW SHOWS SOME DEFORMATION TO THE THREADING WHICH IS CONSISTENT WITH INSERTION AND REMOVAL. DRAWING NUMBER 458_940 REV. K WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. NO PRODUCT ISSUE WAS IDENTIFIED IN THE COMPLAINT DESCRIPTION OR NOTED UPON EXAMINATION. THE RETURNED 456.305 HELICAL BLADE SHOWS MODERATE WEAR, SCUFF MARKS AND DISCOLORATION CONSISTENT WITH INSERTION, EXTENDED IMPLANTATION AND REMOVAL. THE DEVICE WAS RETURNED AND REPORTED TO HAVE MIGRATED AND GONE THROUGH THE ACETABULUM CAUSING PAIN. THIS CONDITION IS UNCONFIRMED AS NO X-RAYS WERE PROVIDED. AS REPORTED IN THE COMPLAINT, IT IS LIKELY THAT POOR BONE QUALITY ALLOWED THE IMPLANT TO MIGRATE. THIS WAS LIKELY CAUSED BY THE PATIENT¿S ADVANCED AGE AND OSTEOPOROSIS. DRAWING (B)(4) WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. IT IS LIKELY THAT POOR BONE QUALITY CAUSED BY A COMORBIDITY LED TO THIS UNCONFIRMED COMPLAINT FOR THE 456.305 HELICAL BLADE; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO PRODUCT ISSUE WAS IDENTIFIED IN THE COMPLAINT OR NOTED UPON EXAMINATION OF THE RETURNED 456.322 NAIL OR 458.940 SCREW. 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

    IT WAS REPORTED A REVISION SURGERY DUE TO THE FEMORAL BLADE OF THE PATIENT'S TROCHANTERIC FIXATION NAIL GOING THROUGH THE ACETABULUM AND PAIN. THE PATIENT WAS ORIGINALLY TREATED FOR A HIP FRACTURE ON (B)(6) 2014. ON A UNKNOWN DATE, DURING A ROUTINE FOLLOW-UP, THE PATIENT COMPLAINED OF PAIN, THE EVENT WAS CONFIRMED VIA-X-RAYS. IT WAS NOTED THAT THE EVENT OCCURRED DUE TO THE BONE BEING "BAD". THE SURGEON REVISED THE PATIENT'S SURGERY TO A TOTAL HIP REPLACEMENT AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO OPERATIVE DELAYS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429921 11.0MM TI HELICAL BLADE 100MM ROD,FIXATION,INTRAMEDULLARY,SCREW,FIXATION,BONE HSB SYNTHES ELMIRA 7503517

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention