BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4002898 · Received August 12, 2014

    Report

    Report Number
    1526439-2014-11745
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    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. (B)(6). THIS REPORT IS FOR THE UNKNOWN PLATE (73 YEAR OLD FEMALE WITH EXTENSOR POLLICIS RUPTURE SIX WEEKS POST FRACTURE SECONDARY TO SCREW PENETRATION). 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.

    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.

    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 (B)(6) 2004 TO (B)(6) 2005, 40 PATIENTS WERE STUDIED WHO WERE TREATED WITH LOCKED VOLAR PATES FOR UNSTABLE DISTAL RADIAL FRACTURES. THE SYNTHES (B)(4) 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 FLEXION, 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 POLLICIS 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 PATIENTS IN THIS ARTICLE. THE REST OF THE PATIENTS ARE NOT IDENTIFIABLE. THIS MEDWATCH IS FOR UNKNOWN PLATE ((B)(6) FEMALE PATIENT WITH POLLICIS LONGUSTENDON RUPTURE SECONDARY TO SCREW PENETRATION). THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480373 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR