BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR

    MDR report key: 4637472 · Received March 27, 2015

    Report

    Report Number
    2520274-2015-12287
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    October 18, 2008
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWB
    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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, BAE J., HUR C., OH C., OH J. (18 OCTOBER 2008). TECHNICAL DIFFICULTIES OF REMOVAL OF LOCKING SCREW AFTER LOCKING COMPRESSION PLATING. ARCH ORTHOP TRAUMA SURG, VOLUME 129, PAGES 91-95. THE DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THIS REPORT IS FOR A AN UNKNOWN 3.5 CONICAL EXTRACTION SCREW/QUANTITY 1/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. (B)(4). 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, BAE J., HUR C., OH C., OH J. (18 OCTOBER 2008). TECHNICAL DIFFICULTIES OF REMOVAL OF LOCKING SCREW AFTER LOCKING COMPRESSION PLATING. ARCH ORTHOP TRAUMA SURG, VOLUME 129, PAGES 91-95. FROM JANUARY 2004 TO DECEMBER 2007, THE REPORTERS REMOVED 159 5.0-SELF TAPPING LOCKING SCREWS, 279 3.5-SELF TAPPING LOCKING SCREWS, 198 AO-3.5 CORTICAL AND 4.0 CANCELLOUS SCREWS FROM VARIOUS SITES FOR A TOTAL OF 58 PATIENTS. FOR 50 PATIENTS LOCKING COMPRESSION PLATES (LCP, SYNTHES, (B)(4)) WERE REMOVED AFTER SOLID UNION. FOR EIGHT PATIENTS, PLATES WERE TAKEN OUT BEFORE UNION DUE TO ACUTE POSTOPERATIVE INFECTION IN TWO PATIENTS, LATE ONSET INFECTION IN THREE PATIENTS, A REVISION OF THE MALALIGNMENT IN TWO PATIENTS AND REVISION OF NONUNION IN ONE PATIENT. A TOTAL OF 24 3.5-SELF TAPPING LOCKING SCREWS WERE REMOVED WITH MANY DIFFICULTIES DUE TO THE STRIPPING OF THE HEXAGONAL RECESS. CONICAL SCREW EXTRACTION SETS WERE USED TO REMOVE THESE SCREWS. ONLY FOUR STRIPPED SCREWS WERE REMOVED USING A 2.5 CONICAL EXTRACTION SCREW (PART 309.521 AND PART 309.530) IN THE FIRST ATTEMPT. TWO ADDITIONAL STRIPPED SCREWS WERE REMOVED USING A 3.5 CONICAL EXTRACTION SCREW. MANY DIFFICULTIES WERE EXPERIENCED FOR THE REMOVAL OF REMAINING 18 STRIPPED SCREWS. SCREWS WERE REMOVED BY BENDING THE PLATE OVER THE HOLE FIXED WITH STRIPPED SCREW, THE LOCKING HOLE WAS DEFORMED AS THE PLATE WAS BENT AROUND THAT HOLE AND THE STRIPPED SCREWS WERE DISLODGED FROM THE HOLE AND WERE THEN REMOVED USING VICE-GRIP; PLATE WAS CUT WITH A HIGH-SPEED METAL CUTTING SAW FOR REMAINING MOST OF THE REMAINING STRIPPED SCREWS; AND BENDING OF THE PLATE AT THE STRIPPED SCREW AND REMOVAL OF SCREW BY ROTATING THE PLATE AROUND THE SCREW. ONE OF THE 3.5-CORTICAL SCREWS WAS STRIPPED AT THE TIME OF REMOVAL, THE PLATE WAS REMOVED AFTER DESTROYING THE SCREW HEAD AND THE SHAFT OF THE SCREW WAS LEFT WITHIN THE BONE. (B)(4). THIS REPORT IS FOR AN UNKNOWN 3.5 CONICAL EXTRACTION SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204802 EXTRACTOR HWB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1