BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5410535 · Received February 4, 2016

    Report

    Report Number
    2520274-2016-10748
    Event Type
    Injury
    Date Received
    February 4, 2016
    Report Date
    January 15, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MÜHLDORFER-FODOR, M., REGER, A., VAN SCHOONHOVEN, J., MITTLMEIER, T., AND PROMMERSBERGER, K.J. (2015). THE EFFECT OF MIDCARPAL VERSUS TOTAL WRIST FUSION ON THE HAND¿S LOAD DISTRIBUTION DURING GRIPPING. J HAND SURG AM. 40, 2183-2190. THIS REPORT IS FOR AN UNKNOWN LCP WRIST FUSION SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. ADDITIONAL DEVICE PRODUCT CODE: HWC. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, M܈LDORFER-FODOR, M., REGER, A., VAN SCHOONHOVEN, J., MITTLMEIER, T., AND PROMMERSBERGER, K.J. (2015). THE EFFECT OF MIDCARPAL VERSUS TOTAL WRIST FUSION ON THE HAND'S LOAD DISTRIBUTION DURING GRIPPING. J HAND SURG AM. 40, 2183-2190. THE AUTHORS CONDUCTED A STUDY TO ANALYZE THE TOTAL GRIP FORCE AND LOAD DISTRIBUTION OF THE HAND WITH MIDCARPAL FUSION (MCF) AND TOTAL WRIST FUSION (TWF). ALL PATIENTS WITH TWF WERE TREATED WITH SYNTHES WRIST FUSION PLATE, THE LOCKING COMPRESSION PLATE (LCP) WRIST FUSION SYSTEM, WHICH WAS DISTALLY FIXED TO THE THIRD METACARPAL. FOR MCF (SCAPHOID EXCISION AND 4-CORNER ARTHRODESIS), THE ARTHRODESIS WAS STABILIZED WITH THREE TO FOUR KIRSCHNER WIRES, WHICH WERE REMOVED 12 WEEKS LATER. TWELVE PATIENTS WITH UNILATERAL TWF AND 12 PATIENTS WITH UNILATERAL MCF WERE ASSESSED AT AN AVERAGE 64 MONTHS (RANGE, 19-100 MONTHS) POSTOPERATIVELY. THE TOTAL GRIP FORCE AND LOAD DISTRIBUTION OF BOTH HANDS WERE MEASURED BY THE MANUGRAPHY SYSTEM. THE AVERAGE AGE OF THE PATIENTS AT THE TIME OF SURGERY WAS 41 YEARS (RANGE, 25-56 YEARS) IN THE TWF GROUP AND 38 YEARS (RANGE, 24-51 YEARS) IN THE MCF GROUP. IN BOTH GROUPS, 11 PATIENTS WERE MEN. PATIENTS RETURNED FOR A FOLLOW-UP AT AN AVERAGE OF 57 MONTHS (RANGE, 19-100 MONTHS) AFTER TOTAL WRIST ARTHRODESIS AND 71 MONTHS (RANGE, 20-98 MONTHS) AFTER SCAPHOID EXCISION AND MIDCARPAL ARTHRODESIS. RADIOGRAPHS OF THE OPERATED WRIST WERE TAKEN AT FOLLOW-UP. RESULTS INCLUDED: TWO PATIENTS WITH TWF HAD SOME EXTENSOR TENDON IRRITATION. AVERAGE PATIENT-RATED PAIN WITH STRAIN IN THE OPERATED HAND, WHICH WAS RATED ON A 10-POINT VISUAL ANALOG SCALE, WAS 3.4 (RANGE, 0-8) WITH TWF. AVERAGE GRIP FORCE WAS SIGNIFICANTLY LOWER IN THE OPERATED HAND THAN IN THE NONSURGICAL HAND. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LCP WRIST FUSION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70025 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention