BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3995943 · Received August 8, 2014

    Report

    Report Number
    2520274-2014-12928
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PROXIMAL HUMERAL FRACTURES WITH A SEVERE VARUS DEFORMITY TREATED BY FIXATION WITH A LOCKING PLATE." ROBINSON C.M., WYLIE J.R., RAY A.G., DEMPSTER N.J., OLABI B., SEAH K.T.M., AKHTAR M.A. JOURNAL OF BONE AND JOINT SURGERY - SERIES B. 2010; 92(5):672-678. THIS REPORT IS FOR UNKNOWN 3.5MM CANNULATED SCREWS. (B)(4) 2 SUBACROMIAL IMPINGEMENTS, 2 STIFFNESS, 1 MALPOSITION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NOT CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿PROXIMAL HUMERAL FRACTURES WITH A SEVERE VARUS DEFORMITY TREATED BY FIXATION WITH A LOCKING PLATE." ROBINSON C.M., WYLIE J.R., RAY A.G., DEMPSTER N.J., OLABI B., SEAH K.T.M., AKHTAR M.A. JOURNAL OF BONE AND JOINT SURGERY - SERIES B. 2010; 92(5):672-678. IN THIS ARTICLE THE AUTHOR STUDIED A CONSECUTIVE SERIES OF PATIENTS WITH PROXIMAL HUMERAL FRACTURES IN WHICH THERE WAS A VARUS DEFORMITY OF THE HUMERAL HEAD. WE TREATED 47 PATIENTS (21 MEN, 26 WOMEN) WITH A MEAN AGE OF 57 YEARS (22 TO 88) WHO HAD A PROXIMAL HUMERAL FRACTURE IN WHICH THERE WAS A SEVERE VARUS DEFORMITY, USING A STANDARD OPERATIVE PROTOCOL OF ANATOMICAL REDUCTION, FIXATION WITH A PROXIMAL HUMERAL LOCKING PLATE (PHILOS PLATE, SYNTHES). FRAGMENTS OF THE TUBEROSITIES WHICH HAD CONSIDERABLE MARGINAL PORTIONS OF THE ARTICULAR SURFACE ATTACHED WERE REDUCED THROUGH A ROTATOR INTERVAL ARTHROTOMY AND FIXED USING 3.5MM CANNULATED SCREWS (SYNTHES OR COMPETITOR SCREWS). SEVEN OF THE PATIENTS UNDERWENT FURTHER SURGERY, TWO FOR FAILURE OF FIXATION, THREE FOR DYSFUNCTION OF THE ROTATOR CUFF, AND TWO FOR SHOULDER STIFFNESS. THE TWO CASES OF FAILURE OF FIXATION WERE ATTRIBUTABLE TO VIOLATION OF THE OPERATIVE PROTOCOL. IN THE 46 PATIENTS WHO RETAINED THEIR HUMERAL HEAD, ALL THE FRACTURES HEALED WITHIN THE FIRST YEAR, WITH NO SIGN OF COLLAPSE OR NARROWING OF THE JOINT SPACE. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4). THIS REPORT IS FOR UNKNOWN 3.5MM CANNULATED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472724 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention