BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4627766 · Received March 24, 2015

    Report

    Report Number
    2520274-2015-12045
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BAHARI, S., LENEHAN, B., KHAN, H., AND MCELWAIN, J. P. (2007). MINIMALLY INVASIVE PERCUTANEOUS PLATE FIXATION OF DISTAL TIBIA FRACTURES. ACTA ORTHOP BELG, 73, 635-640. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT/UNKNOWN QUANTITY. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT 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. BAHARI, S., LENEHAN, B., KHAN, H., AND MCELWAIN, J. P. (2007). MINIMALLY INVASIVE PERCUTANEOUS PLATE FIXATION OF DISTAL TIBIA FRACTURES. ACTA ORTHOP BELG, 73, 635-640. THE TREATMENT OF UNSTABLE DISTAL TIBIA OR PILON FRACTURES REMAINS CONTROVERSIAL. REPORTS FROM VARIOUS INSTITUTIONS SUGGEST TREATMENT MODALITIES RANGING FROM MINIMALLY INVASIVE TECHNIQUE, OPEN REDUCTION AND INTERNAL FIXATION (ORIF), INTRAMEDULLARY NAILING (IM), HYBRID OR RING EXTERNAL FIXATION. PATIENTS WITH DISTAL TIBIA OR PILON FRACTURES TREATED IN OUR INSTITUTION WERE PROSPECTIVELY FOLLOWED. AP AND LATERAL FULL LENGTH VIEW OF THE TIBIA AND FIBULA AND DEDICATED ANKLE RADIOGRAPHS WERE TAKEN IN ALL CASES. ALL FRACTURES WERE CLASSIFIED USING THE AO CLASSIFICATION AND INTRA-ARTICULAR FRACTURES WERE FURTHER CLASSIFIED USING THE RUEDI & ALLGÖWER CLASSIFICATION. FRACTURES WERE CONSIDERED HEALED WHEN MATURE BRIDGING CALLUS WAS IDENTIFIED ON TWO VIEWS AND PATIENTS REPORTED NO PAIN ON FULL WEIGHT BEARING. SOFT TISSUE OUTCOME WAS ASSESSED FROM HISTORY OF WOUND INFECTION, WOUND DEHISCENCE, PLATE IMPINGEMENT AND PLATE REMOVAL. BETWEEN JANUARY 2004 AND DECEMBER 2005, 48 PATIENTS WITH DISTAL TIBIA OR PILON FRACTURE WERE TREATED WITH THE AO DISTAL TIBIA LOCKING PLATE (SYNTHES). FORTY-TWO PATIENTS, 31 MALE AND 11 FEMALE, WERE AVAILABLE FOR FOLLOW-UP. MEAN AGE WAS 35 YEARS (RANGE, 17-75). THE MEAN FOLLOW-UP TIME WAS 19.6 MONTHS (RANGE, 9¿24). MEAN TIME TO FRACTURE HEALING WAS 22.4 WEEKS. THERE WERE ONE CASE OF HARDWARE FAILURE DUE TO SCREW BREAKAGE AND TWO OF SUPERFICIAL INFECTION. THERE WAS ONE CASE OF DEEP INFECTION THAT NECESSITATED HARDWARE REMOVAL. STAPHYLOCOCCUS AUREUS WAS CULTURED. THREE PATIENTS HAD METALWORK REMOVAL DUE TO PLATE IMPINGEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO DISTAL TIBIA LOCKING PLATE. THIS MEDWATCH REFERS TO AN UNKNOWN SCREW AND REFERS TO BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196908 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1