BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 TIBIA

    MDR report key: 5475944 · Received March 3, 2016

    Report

    Report Number
    0009610622-2016-00087
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THE SUBJECT PRODUCT TO BE A CONCOMITANT ITEM. THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. WE RESERVE THE RIGHT TO REOPEN AND UPDATE THE FILE IN CASE ADDITIONAL INFORMATION WILL BE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PATIENT WAS HAVING A T2 TIBIAL NAIL INSERTED FOR FRACTURE, THE NAIL HOLDING BOLT WENT INTO NAIL ADAPTER EASILY, NURSE NOTICED SURGEON STRUGGLING WITH ATTACHING NAIL TO BOLT. NAIL ATTACHED TO JIG WITH NAIL HOLDING BOLT. NAIL HOLDING BOLT AND NAIL ADHERED TOGETHER. NAIL HOLDING BOLT UNABLE TO BE UNSCREWED FROM NAIL. T2 TIBIAL NAIL 18220936S, LOT K0C2702. TROCAR LONG CAT 18060215, LOT K0606 WAS DAMAGED IN THE PROCESS OF TRYING TO DIS-ENGAGE NAIL FROM BOLT. NAIL HOLDING BOLT ITEM 18060370 LOT NUMBER NOT ABLE TO BE VISUALIZE AS IT IS STUCK IN NAIL ADAPTER. NAIL ADAPTER TIBIA 18061002 LOT KHI001104. ANOTHER NAIL WAS NOT AVAILABLE ON SHELF; SURGEON WAS NOT ABLE TO WAIT FOR A REPLACEMENT ITEM TO ARRIVE FROM THE WAREHOUSE. TIBIA REAMED UP FROM 10.5MM TO 11.5MM, TO ACCOMMODATE NAIL 10MM NAIL ((B)(4)) OPERATING TIME EXTENDED AN HOUR AS A RESULT - TIBIA HAD TO BE RE-REAMED AND A SCREW ALREADY IN SITU ALSO HAD TO BE REMOVED. NO ADVERSE CONSEQUENCES TO SURGICAL OUTCOME BY GOING UP A DIAMETER IN NAIL SIZE; AS SPECIFIED BY DR. TROCAR ((B)(4)) WAS DAMAGED, SECOND KIT REQUIRED AND ARRIVED IN TIME FOR THE TROCAR TO BE USED; NO DELAY TO OPERATING TIME AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PATIENT WAS HAVING A T2 TIBIAL NAIL INSERTED FOR FRACTURE, THE NAIL HOLDING BOLT WENT INTO NAIL ADAPTER EASILY, NURSE NOTICED SURGEON STRUGGLING WITH ATTACHING NAIL TO BOLT. NAIL ATTACHED TO JIG WITH NAIL HOLDING BOLT. NAIL HOLDING BOLT AND NAIL ADHERED TOGETHER. NAIL HOLDING BOLT UNABLE TO BE UNSCREWED FROM NAIL. T2 TIBIAL NAIL 18220936S, LOT K0C2702. TROCAR LONG CAT 18060215, LOT K0606 WAS DAMAGED IN THE PROCESS OF TRYING TO DIS-ENGAGE NAIL FROM BOLT. NAIL HOLDING BOLT ITEM 18060370 LOT NUMBER NOT ABLE TO BE VISUALIZE AS IT IS STUCK IN NAIL ADAPTER. NAIL ADAPTER TIBIA 18061002 LOT KHI001104. ANOTHER NAIL WAS NOT AVAILABLE ON SHELF; SURGEON WAS NOT ABLE TO WAIT FOR A REPLACEMENT ITEM TO ARRIVE FROM THE WAREHOUSE. TIBIA REAMED UP FROM 10.5MM TO 11.5MM, TO ACCOMMODATE NAIL 10MM NAIL (18221036S, LOT K456076) OPERATING TIME EXTENDED AN HOUR AS A RESULT - TIBIA HAD TO BE RE-REAMED AND A SCREW ALREADY IN SITU ALSO HAD TO BE REMOVED. NO ADVERSE CONSEQUENCES TO SURGICAL OUTCOME BY GOING UP A DIAMETER IN NAIL SIZE; AS SPECIFIED BY DR. TROCAR (18060215) WAS DAMAGED, SECOND KIT REQUIRED AND ARRIVED IN TIME FOR THE TROCAR TO BE USED; NO DELAY TO OPERATING TIME AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133613 NAIL HANDLE T2 TIBIA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KHI001104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other