BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA3 LAG SCREW CASE 2

    MDR report key: 11114353 · Received January 4, 2021

    Report

    Report Number
    0009610622-2021-00036
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    August 12, 2012
    Report Date
    March 8, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED CUTOUT MENTIONED IN THE ARTICLE COULD NOT BE CONFIRMED, HOWEVER, THE LITERATURE CLEARLY INDICATES THAT THE POSITION OF THE LAG SCREW WAS NOT OPTIMAL (TOO ANTERIOR) AND TAD WAS MORE THAN 25MM. THE EVENT CAN BE THEN CLASSIFIED AS USER-RELATED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY TRAUMA DEPARTMENT, HANNOVER MEDICAL SCHOOL IN GERMANY. THE TITLE OF THIS REPORT IS ¿TIP APEX DISTANCE, HIP SCREW PLACEMENT, AND NECK SHAFT ANGLE AS POTENTIAL RISK FACTORS FOR CUT-OUT FAILURE OF HIP SCREWS AFTER SURGICAL TREATMENT OF INTERTROCHANTERIC FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT DOI 10.1007/S00264-012-1636-0. THIS REPORT INCLUDES RESEARCH DONE ON 47 PATIENTS BETWEEN THE PERIOD JANUARY 2007 AND MAY 2010. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES (2) CASES OF CUT-OUT. THE REPORT STATES CUT-OUT WAS DEFINED AS PROJECTION OF THE SCREW FROM THE FEMORAL HEAD BY MORE THAN 1 MM. PATIENTS WITH CUT-OUT TENDED TO HAVE A MORE POSTERIOR SCREW POSITION.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY TRAUMA DEPARTMENT, HANNOVER MEDICAL SCHOOL IN GERMANY. THE TITLE OF THIS REPORT IS ¿TIP APEX DISTANCE, HIP SCREW PLACEMENT, AND NECK SHAFT ANGLE AS POTENTIAL RISK FACTORS FOR CUT-OUT FAILURE OF HIP SCREWS AFTER SURGICAL TREATMENT OF INTERTROCHANTERIC FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT DOI 10.1007/S00264-012-1636-0. THIS REPORT INCLUDES RESEARCH DONE ON 47 PATIENTS BETWEEN THE PERIOD JANUARY 2007 AND MAY 2010. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES (2) CASES OF CUT-OUT. THE REPORT STATES CUT-OUT WAS DEFINED AS PROJECTION OF THE SCREW FROM THE FEMORAL HEAD BY MORE THAN 1 MM. PATIENTS WITH CUT-OUT TENDED TO HAVE A MORE POSTERIOR SCREW POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3309 UNKNOWN GAMMA3 LAG SCREW CASE 2 IMPLANT HWC STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R