BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3905496 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12248
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 12, 2012
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. TREATMENT OF TWO-PART PROXIMAL HUMERUS FRACTURES: INTRAMEDULLARY NAIL COMPARED TO LOCKED PLATING. HOSPITAL FOR SPECIAL SURGERY BY LEKIC, N., MONTERO, N.M., TAKEMOTO, R.C., DAVIDOVITCH, R.I., EGOL, K.A., (2012), P86-91. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF LOCKING (MINIMUM QUANTITY 5) AND NON-LOCKING SCREWS (QUANTITY UNKNOWN) WITH UNKNOWN PART AND LOT NUMBERS. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE BY LEKIC, N., MONTERO, N.M., TAKEMOTO, R.C., DAVIDOVITCH, R.I., EGOL, K.A.: TREATMENT OF TWO-PART PROXIMAL HUMERUS FRACTURES: INTRAMEDULLARY NAIL COMPARED TO LOCKED PLATING. HOSPITAL FOR SPECIAL SURGERY, (2012), P86-91. THE PURPOSE OF THIS STUDY WAS TO COMPARE A LOCKING PLATE (LP) WITH SCREWS VS. INTRAMEDULLARY NAILING (IMN) FOR TWO¿PART PROXIMAL HUMERUS FRACTURES, SPECIFIC TO ALIGNMENT, HEALING, PATIENT OUTCOMES, AND COMPLICATIONS. THE STUDY WAS A RETROSPECTIVE CHART REVIEW AND WAS PERFORMED ON 24 CASES OF DISPLACED TWO-PART SURGICAL NECK FRACTURES OF THE HUMERUS. TWELVE SHOULDERS WERE TREATED USING IMN FIXATION (COMPETITOR PRODUCT) AND 12 OTHERS WERE FIXATED WITH LP. SURGERY WAS PERFORMED BY A SINGLE TRAUMA-TRAINED SURGEON OVER A 7 YEAR PERIOD. THE 12 PATIENTS (2 MALE, 10 FEMALE) WITH AN AVERAGE AGE OF 59 YEARS OLD, RANGING FROM 21-81 YEARS, AND WERE TREATED WITH A PRE-CONTOURED LP AND SCREW CONSTRUCT (SYNTHES, (B)(6)). MECHANISM OF INJURY INCLUDED 11 FALLS FROM STANDING HEIGHT AND 1 MOTOR VEHICLE ACCIDENT. OPERATIVE TECHNIQUE INCLUDED PROXIMAL LOCKING SCREW PLACEMENT THAT WAS CONFIRMED TO BE WITHIN THE HUMERAL HEAD WITH INTRA-OPERATIVE FLUOROSCOPY. A MINIMUM OF FIVE SCREWS WERE USED IN THE HUMERAL HEAD TO ACHIEVE FIXATION. THE DISTAL SHAFT SCREWS WERE A COMBINATION OF LOCKED AND NON-LOCKED SCREWS DEPENDING ON THE BONE QUALITY. THE NUMBER OF SCREWS USED WAS AT THE DISCRETION OF THE TREATING SURGEON. THIS REPORT IS FOR (B)(4) FOR LOCKING (MINIMUM QUANTITY 5) AND NON-LOCKING SCREWS (QUANTITY UNKNOWN) WITH UNKNOWN PART AND LOT NUMBERS, AND INCLUDES THE FOLLOWING EVENTS: THREE OF THE PATIENTS EXPERIENCED SCREW PENETRATION WITH TWO OF THEM HAVING HARDWARE REMOVAL. THIS DETERMINATION IS FOR THE PATIENT IDENTIFIED AS NUMBER 3 IN THE LOCKING PLATE GROUP. PATIENT NUMBER 3 IS A MALE, (B)(6). HIS MECHANISM OF INJURY IS A FALL. AT HIS 11 MONTH FOLLOW UP, IT WAS IDENTIFIED HE HAD SCREW PENETRATION. IT WAS NOT CLEARLY IDENTIFIED IF PATIENT NUMBER 3 HAD HARDWARE REMOVAL. NO ADDITIONAL DETAILS AVAILABLE. A COPY OF THE LITERATURE ARTICLE IS BEING ATTACHED TO THIS MEDWATCH. THIS IS REPORT 5 OF 8 MEDWATCH REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385072 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention