BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 3152086 · Received June 7, 2013

    Report

    Report Number
    1719045-2013-01539
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CRITERION TOOL AND DIE MANUFACTURED THE DRIVE SHAFT ASSEMBLY PN 314.743, LOT 5816845. DUE TO AN UNKNOWN CAUSE, DRIVE SHAFT ASSEMBLY HAS A BROKEN TIP. THE MATERIAL OF THE SHAFT WAS DETERMINED TO BE WITHIN SPECIFICATION, BUT THE HARDNESS COULD NOT BE DETERMINED DUE TO THE THIN WALL CANNULATION. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DIAMETER OF THE DRIVE SHAFT WAS MEASURED TO BE OVER SIZED. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED: A SURGEON WAS USING THE RIA TO REAM OUT AND IRRIGATE THE INFECTED CANAL OF A TIBIA. IN THE PROCESS OF DOING THE PROCEDURE THE RIA LOCKING FELL OFF AND LANDED ON THE FLOOR. THE SURGEON CONTINUED WITH THE PROCEDURE HOLDING THE REAMER DRIVE SHAFT AND RIA TUBE ASSEMBLY TOGETHER WITHOUT THE CLIP. THE SURGEON DECIDED NOT TO USE THE SPARE LOCKING CLIP THAT WAS IN THE SET. ONCE THE PROCEDURE WAS OVER IT WAS VISIBLE ON X-RAY THAT THERE WERE FRAGMENTS OF METAL INSIDE THE PATIENTS INTRAMEDULLARY CANAL. ON INSPECTION THE RIA INTRAMEDULLARY REAMER 12.5MM HAD BEEN BROKEN AND THE END OF THE REAMER DRIVE SHAFT HAD ALSO BEEN DAMAGED. THE SURGEON WAS ABLE TO REMOVE SOME OF THE FRAGMENTS BUT SEVERAL REMAINED INSIDE THE PATIENT. THE SURGEON DECIDED TO LEAVE THE SMALL METAL SHARDS INSIDE THE PATIENT DUE TO THE DAMAGE IT WOULD CAUSE TO REMOVE THEM. THE SURGEON SUGGESTED IT MAY HAVE BEEN THE REAMER DRIVE SHAFT NOT ENGAGING THE INTRAMEDULLARY REAMER, DUE TO THE ABSENCE OF THE LOCKING CLIP, THAT CAUSE THE SHEERING OFF OF THE METAL. PATIENT OUTCOME WAS NOT IMPACTED, FRAGMENTS ARE SECURED IN THE INTRAMEDULLARY CANAL. PROCEDURE TIME MIGHT HAVE INCREASED BY APPROXIMATELY 10 MINUTES. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252252 RIA DRIVESHAFT L520 HTO SYNTHES GMBH 15805-01

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR