BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM

    MDR report key: 5475955 · Received March 3, 2016

    Report

    Report Number
    0009610622-2016-00088
    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

    ALTHOUGH REPEATEDLY REQUESTED FURTHER PRODUCT DETAILS OR THE PRODUCTS WERE NOT AVAILABLE. THE IMPLANT AND INSTRUMENTS WERE NOT AVAILABLE; THEREFORE AN INSPECTION WAS NOT POSSIBLE. THE NAIL AND NAIL HOLDING SCREW WERE CLASSIFIED AS PRIMARY PRODUCTS BASED ON THE EVENT DESCRIPTION. A REVIEW OF THE DHR FOR THE NAIL REVEALED NO DISCREPANCIES. CATALOGUE NUMBER AND LOT CODE FOR THE NAIL HOLDING SCREW WERE NOT AVAILABLE. THEREFORE THE DHR COULD NOT BE REVIEWED. BASED ON THE ABOVE FACTS AND SPARSE INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. THE INVESTIGATION OF THIS CASE WILL BE CLOSED BASED ON THE AVAILABLE INFORMATION. WE RESERVE THE RIGHT TO RE-OPEN THE INVESTIGATION IN CASE THAT FURTHER SUBSTANTIAL INFORMATION BECOMES AVAILABLE.

    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, LOK456076) 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.

    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, LOK456076) 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
    133685 NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other