BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IASSIST KNEE SYSTEM

    MDR report key: 5441053 · Received February 17, 2016

    Report

    Report Number
    9617840-2016-00001
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    February 25, 2015
    Report Date
    February 25, 2015
    Manufacturer
    ZIMMER CAS, MONTREAL, QUEBEC, CANADA
    Product Code
    OLO
    PMA / PMN Number
    K122326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INVESTIGATION IT WAS FOUND THAT THE SAW GUIDE MOVEMENT COULD ONLY BE REPRODUCED IF THE USE OF THE TROCAR PIN WAS OMITTED TO HOLD THE SAW SLOT ONCE THE RESECTION LEVEL IS ADJUSTED AS IS REQUIRED. THE SURGEON REPORTED THAT HE HAD TIGHTENED THE SET SCREW. HOWEVER, THE SCREW ON THE SAW-SLOT/FEMORAL-CUT-GUIDE ASSEMBLY IS USED AND ONLY INTENDED TO ADJUST THE RESECTION DEPTH WITH ONLY LIMITED HOLDING CAPACITY. THE USE OF A USE TROCAR PIN IN THE CORRESPONDING HOLES IN THE SAW GUIDE IS INDICATED IN THE SURGICAL TECHNIQUE INSTRUCTIONS TO HOLD THE SAW SLOT WHILE CUTTING ONCE THE RESECTION DEPTH HAS BEEN ADJUSTED.

    Description of Event or Problem · 1

    DURING A TKR SURGERY IN THE U.S.A. USING THE IASSIST KNEE SYSTEM, THE SURGEON COMPLAINED THAT THE SAW SLOT INSTRUMENT MOVED AS HE WAS SAWING AFTER HAVING ADJUSTED THE RESECTION LEVEL. THIS WAS DETECTED IMMEDIATELY AFTER WHICH THE SURGEON INDICATED THAT HE RE-TIGHTENED THE SCREW AND AGAIN THE ASSEMBLY MOVED AS HE TRIED CUTTING AGAIN. THE CUT WAS REPORTEDLY UNEVEN AND OVER-RESECTED. THE SURGEON DISCONTINUED THE USE OF THE SYSTEM AND USED THE IMPLANT INSTRUMENTATION INSTEAD TO CORRECT THE CUTS AND COMPLETE THE SURGERY. THERE WAS A SURGICAL TIME EXTENSION OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98322 IASSIST KNEE SYSTEM FEMORAL SAW SLOT OLO ZIMMER CAS, MONTREAL, QUEBEC, CANADA 20-8011-042-00 130417-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention