BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-CLIP F/RIA

    MDR report key: 3152047 · Received June 7, 2013

    Report

    Report Number
    1719045-2013-01540
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    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. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 7131681 REVEALED THE LOCK-CLIP FOR RIA-STERILE WAS MANUFACTURED BY (B)(4), ORIGINALLY PO 1472334, FOR (B)(4) PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER NS014812 REVISION B ON 1/15/13. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 1/9/13. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 2/13/13. NO NON CONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    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 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252860 LOCK-CLIP F/RIA HTO SYNTHES MONUMENT 7131681

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR