BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5049300 · Received September 2, 2015

    Report

    Report Number
    2520274-2015-15609
    Event Type
    Injury
    Date Received
    September 2, 2015
    Report Date
    August 17, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. VAN EMBDEN, D., ET AL (2015). THE STABILITY OF FIXATION OF PROXIMAL FEMORAL FRACTURES. BONE JOINT J. 97-B(3), 391-397 THIS REPORT IS FOR AN UNKNOWN SCREW. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, VAN EMBDEN, D., ET AL (2015). THE STABILITY OF FIXATION OF PROXIMAL FEMORAL FRACTURES. BONE JOINT J. 97-B(3), 391-397. THE AIM OF THIS STUDY WAS TO USE RADIOSTEREOMETRIC ANALYSIS (RSA) TO QUANTIFY THE MOVEMENT OF PROXIMAL FEMORAL FRACTURE FRAGMENTS AFTER FIXATION WITH THE MOST COMMONLY USED METHODS OF OSTEOSYNTHESIS (GAMMA NAIL, DYNAMIC HIP SCREW AND CANNULATED SCREW). UNDISPLACED INTRACAPSULAR FRACTURES OF THE HIP ARE OFTEN TREATED WITH EITHER A SLIDING HIP SCREW SUCH AS A SYNTHES DYNAMIC HIP SCREW (DHS) OR THREE SYNTHES CANNULATED SCREWS (CS). BETWEEN APRIL 2010 AND APRIL 2012, ALL PATIENTS AGED > 60 YEARS WHO WERE ADMITTED TO LEIDEN UNIVERSITY MEDICAL CENTER'S DEPARTMENTS OF TRAUMA AND ORTHOPAEDIC SURGERY WITH EITHER AN AO 31-B15 FRACTURE OF THE FEMORAL NECK OR AN AO 31-A2 TROCHANTERIC FRACTURE PLANNED FOR OSTEOSYNTHESIS, WERE ENROLLED AFTER PROVIDING WRITTEN INFORMED CONSENT. IN TOTAL, 31 PATIENTS WERE INCLUDED: 15 CONSECUTIVE PATIENTS WITH AN UNDISPLACED FRACTURE OF THE FEMORAL NECK WERE TREATED WITH A DHS (N = 6) OR A CS (N = 9), AND 16 CONSECUTIVE PATIENTS WITH A TROCHANTERIC FRACTURE WERE TREATED WITH A DHS (N = 10) OR A GAMMA NAIL (GN) (N = 6). IN UNDISPLACED FRACTURES OF THE FEMORAL NECK, BOTH CRY AND CY REMAIN STABLE AFTER AN INITIAL MIGRATION UP TO THE FOUR MONTH FOLLOW-UP. THE MEAN CRY AT FOUR MONTHS WAS 5.5° (-3.6° TO 14.0°). A WIDE RANGE OF ROTATION, BETWEEN -28.2° AND 11.6° THE FIRST FOUR MONTHS, WAS MAINLY CAUSED BY PATIENT 6 (-28.2°). THE MEAN SHORTENING (CY) IN UNDISPLACED FRACTURES OF THE FEMORAL NECK AT FOUR MONTHS WAS 5.4 MM (-0.04 TO 16.1). THE MEAN ROTATION (CRY) IN TROCHANTERIC FRACTURES WAS 10.6° (-28.1° TO 6.1°) AT FOUR MONTHS. THE MEAN SHORTENING AFTER FOUR MONTHS WAS 5.0 MM (-0.13 TO 12.9). FRACTURES TREATED WITH A DHS (N = 4) HAD A MEAN SHORTENING 7.1 MM (4.6 TO 10.7) AFTER SIX WEEKS. ONE PATIENT (P1, TREATED WITH CS) IN THE UNDISPLACED FRACTURE OF THE FEMORAL NECK GROUP HAD DELAYED UNION AND OSTEONECROSIS (ON) OF THE FEMORAL HEAD THAT LED TO RE-OPERATION AFTER 5.5 MONTHS. THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580928 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention