BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER

    MDR report key: 5549957 · Received April 6, 2016

    Report

    Report Number
    2520274-2016-11973
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Report Date
    March 11, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS IS REPORT #1 OF 2 FOR (B)(4). 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

    THIS DEVICE IS BEING USED FOR TREATMENT AND NOT DIAGNOSIS. DATE RECEIVED BY MANUFACTURE DATE OF MEDWATCH FOLLOW UP 2; SHOULD HAVE BEEN 4/15/2016. 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

    PICHON ET AL.(2007). DRP 2.4 VOLAR PLATING OF DISTAL RADIUS FOR DORSALLY DISPLACED WRIST FRACTURE. ABOUT 22 CASES. HAND SURGERY. HAND SURGERY 26 (2007) 127¿135. THIS REPORT IS FOR UNKNOWN SYNTHES STARDRIVE IMPRINT SCREWDRIVER, UNKNOWN QUANTITY, UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS BEING USED FOR TREATMENT AND 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 LITERATURE ARTICLE, PICHON ET AL.(2007). DRP 2.4 VOLAR PLATING OF DISTAL RADIUS FOR DORSALLY DISPLACED WRIST FRACTURE. ABOUT 22 CASES. HAND SURGERY (2007). FRANCE. RECENT LITERATURE HAS SHOWN THAT THE ANTERIOR OSTEOSYNTHESIS SCREW HEADS LOCKED BY PLATE WAS A RELIABLE CONCEPT IN FRACTURES OF THE DISTAL RADIUS TO POSTERIOR DISPLACEMENT. AFTER BEGINNING OUR EXPERIENCE WITH LCP PLATE 3.5, THE APPLICATION WAS LIMITED TO ONLY EXTRA-ARTICULAR FRACTURES, HERE WE REPORT OUR PRELIMINARY RESULTS WITH THE DRP 2.4. PLATE. BETWEEN JANUARY AND OCTOBER 2004, 22 PATIENTS (16 WOMEN, SIX MEN), UNDERWENT A BONE COMPRESSION DRP 2.4 LOCKING PLATE. SEVENTEEN PATIENTS WERE REVIEWED WITH A MEAN FOLLOW-UP TIME OF 11 MONTHS. ALL FRACTURES HAD CONSOLIDATED, WITH ONLY ONE SECONDARY REDUCTION LOSS. CLINICALLY, THERE WERE SIX EXCELLENT RESULTS, SEVEN GOOD, FOUR AVERAGE AND NO BAD. COMPLICATIONS: WE COUNT FOUR POSTTRAUMATIC REFLEX SYMPATHETIC DYSTROPHY, AND NO NEUROLOGICAL COMPLICATION OR TENDONITIS. SPECIFIC TECHNICAL COMPLICATIONS, TWO PATIENTS PRESENTED PAIN IN THE EXTERNAL STYLOIDIENNE SCREW IN THE GUTTER OF THE PULSE, WHICH JUSTIFIED THE REMOVAL OF OSTEOSYNTHESIS MATERIAL, AND WE HAD TWO INTRAOPERATIVE BREAKAGE OF THE STARDRIVE IMPRINT SCREWDRIVER. RM: TWO INTRAOPERATIVE BREAKAGE OF THE STARDRIVE IMPRINT SCREWDRIVER. THIS IS REPORT #1 OF 3 FOR (B)(4). THIS REPORT IS FOR SYNTHES STARDRIVE IMPRINT SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206810 SCREWDRIVER HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention