BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4003854 · Received August 12, 2014

    Report

    Report Number
    1526439-2014-11737
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KNIGHT,D., HAJDUCKA, C., WILL, E., MCQEEN, M. LOCKED VOLAR PLATING FOR UNSTABLE DISTAL RADIAL FRACTURES: CLINICAL AND RADIOLOGICAL OUTCOMES. INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED (2010) 41:184-189. THIS REPORT IS FOR THE UNKNOWN LOCKING SCREW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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 ARTICLE: LOCKED VOLAR PLATING FOR UNSTABLE FRACTURE:CLINICAL AND RADIOLOGICAL OUTCOMES. KNIGHT, D., HAJDUCKA, C., MCQUEEN, M. (2010). INJURY. INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED 41: 184-189. THIS WAS A RETROSPECTIVE STUDY FROM JANUARY 2004 TO DECEMBER 2005, 40 PATIENTS WERE STUDIED WHO WERE TREATED WITH LOCKED VOLAR PATES FOR UNSTABLE DISTAL RADIAL FRACTURES. THE SYNTHES (B)(6), 3.5 MM DISTAL RADIUS LOCKED VOLAR PLATE WAS USED. THE PURPOSE OF THE STUDY WAS TO IDENTIFY THE FUNCTIONAL AND RADIOLOGICAL OUTCOME OR ANY COMPLICATIONS FOLLOWING THE USE OF FIXED-ANGLE LOCKED T PLATES FOR UNSTABLE FRACTURES OF THE DISTAL RADIUS. THERE WERE 46 CASES WHOSE INITIAL DATA WAS RECORDED PROSPECTIVELY. SIX PATIENTS WERE LOST TO FOLLOW-UP (TWO DIED, TWO MOVED OUT OF THE AREA AND TWO DECLINED TO ATTEND), LEAVING 40 PATIENTS AVAILABLE FOR REVIEW. OF THESE, ONE PATIENT HAD SUFFERED A CONTRALATERAL DISTAL RADIUS INJURY AND WAS EXCLUDED FROM THE FUNCTIONAL TESTS. FINAL REVIEW WAS UNDERTAKEN AT A MEAN OF 59 WEEKS FROM INJURY AND INCLUDED CLINICAL, FUNCTIONAL AND RADIOLOGICAL ASSESSMENT. THERE WERE 35 FEMALES AND FIVE MALES WITH A MEAN AGE OF 59 YEARS. OF THE 40 FRACTURES, SIX LOST CARPAL ALIGNMENT DURING THE PERIOD OF REVIEW. TEN WERE CONSIDERED TO BE MALUNITED AT FINAL REVIEW. THERE WERE 11 CASES OF SCREW PENETRATION INTO THE RADIOCARPAL JOINT AS A CONSEQUENCE OF POSTOPERATIVE COLLAPSE. FUNCTIONALLY, WHEN COMPARED TO THE CONTRALATERAL SIDE, 74% OF EXTENSION, 67%OF FLEXSION, 91% OF PRONATION AND SUPINATION AND 81% OF GRIP STRENGTH WERE REGAINED. MALUNION OCCURRED IN 10 CASES, IN ONE CASE THE PLATE BROKE 4 WEEKS POSTOPERATIVELY AND WAS REVISED AT THAT STAGE. TEN PLATES HAD BEEN REMOVED BY FINAL REVIEW EITHER FOR PLATE FAILURE, PAIN OR RESIDUAL STIFFNESS. THERE WERE FIVE CASES OF EXTENSOR POLLICUS LONGUS TENDON RUPTURES. OF THESE CASES, ONE WAS A (B)(6) FEMALE WHO HAD AN EXTENSOR POLLICIS RUPTURE SIX WEEKS POST FRACTURE SECONDARY TO SCREW PENETRATION. ONE OF THE FIVE CASES ALSO HAD WEAKNESS OF FLEXOR POLLICIS LONGUS FUNCTION. THERE IS ONE IDENTIFIABLE PATIENT IN THE ARTICLE. THE REST OF THE PATIENTS ARE NOT IDENTIFIABLE. THIS MEDWATCH IS FOR UNKNOWN SCREW (PLATE REMOVED FOR MALUNION, PAIN OR RESIDUAL STIFFNESS). THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 2 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478666 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention