BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3 M VARIAX HAND LOCK PLATE,STRAIGHT,16HOLES

    MDR report key: 3092548 · Received May 3, 2013

    Report

    Report Number
    0008031020-2013-00132
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER LEIBINGER-FREIBURG
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED INCIDENT COULD BE CONFIRMED SINCE X-RAYS AND PICTURES SHOW A BROKEN PLATE. THE AFFECTED DEVICE WAS RETURNED TO THE DISTRIBUTION SITE BUT BECAUSE OF A LEGAL ACTION, THE DEVICE COULD NOT HAVE BEEN SENT TO THE INVESTIGATION SITE X-RAYS WERE PROVIDED SHOWING A GAP ON THE FRACTURE SITE, THE COMPRESSION SEEMS TO BE NOT SUFFICIENT FOR A GOOD CONSOLIDATION. THIS COULD BE CONFIRMED WITH THE FOLLOW-UP X-RAYS, THERE IS NO CALLUS FORMATION AFTER 6 WEEKS. IT IS UNUSUAL ESPECIALLY ON A YOUNG MAN WITH GOOD BONE QUALITY. THE DEVICE IS BENT INDICATING SOME FORCE WAS APPLIED ON THE IMPLANTATION SITE. THE 10 WEEKS FOLLOW-UP X-RAYS SHOW A BROKEN DEVICE AND A BIG GAP BETWEEN THE 2 BONE FRAGMENTS. THE BREAKAGE IS A TYPICAL OVERLOAD FAILURE. THEREFORE THIS CASE COULD BE CLASSIFIED AS USER RELATED. THE PATIENT WAS REPORTED TO PLAY GUITAR BEFORE BONE CONSOLIDATION OP REPORTS WERE PROVIDED: THEY READ THERE WAS A NON UNION AFTER 10 WEEKS AND THAT THE PATIENT WAS ABLE TO PLAY GUITAR WITHOUT HAVING PAIN. DURING THE REVISION SURGERY, THE SURGEON NOTICED FIBROUS TISSUES HE HAD TO REMOVE AROUND THE FRACTURE SITE. PLEASE NOTE THAT THE CURRENT IFU READS: POSSIBLE SYSTEM ADVERSE EFFECTS IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN IMPLANT RELATED. NON-UNION OR DELAYED UNION WHICH MAY LEAD TO BREAKAGE OF THE IMPLANT. SEVERE BENDING AND FRACTURE OF AN IMPLANT. INCREASED FIBROUS TISSUE RESPONSE AROUND THE FRACTURE SITE DUE TO UNSTABLE COMMINUTED FRACTURES. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, I HAD A STRYKER IMPLANT PLACED IN MY HAND. AT MY 6 WEEK FOLLOW UP APPOINTMENT, IT WAS DEMONSTRATED THROUGH THE X-RAYS TAKEN THAT THE IMPLANT HAD BENT. FOUR WEEKS LATER ON (B)(6), IT WAS DEMONSTRATED THE THE IMPLANT HAD BROKEN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, I HAD A STRYKER IMPLANT PLACED IN MY HAND. AT MY 6 WEEK FOLLOW UP APPOINTMENT, IT WAS DEMONSTRATED THROUGH THE X-RAYS TAKEN THAT THE IMPLANT HAD BENT. FOUR WEEKS LATER ON (B)(6) IT WAS DEMONSTRATED THE THE IMPLANT HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193892 2.3 M VARIAX HAND LOCK PLATE,STRAIGHT,16HOLES IMPLANT HWC STRYKER LEIBINGER-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention