BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPREADING SCREWDRIVER, BALL TIP GAMMA3® 8 MM

    MDR report key: 16684056 · Received April 5, 2023

    Report

    Report Number
    0009610622-2023-00099
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 6, 2023
    Report Date
    July 18, 2023
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    04546540487667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED DEVICE EXHIBIT SIGNS OF EXTREME USAGE OVER A LONG PERIOD OF TIME. SCRATCHES AND DENTS MARKS CAN BE SEEN ON THE PROXIMAL HEAD AND ON THE BODY. THE BROKEN DISTAL TIP SHOWS DEFORMATION SIGNS DUE TO LONG USAGE. THE BREAKAGE INDICATES TOWARDS APPLICATION OF HIGH TORSIONAL LOAD AND SUDDEN OVERLOADING RESULTING IN BRITTLE FRACTURE AT THE DISTAL END WHICH CAN BE SEEN IN THE MICROSCOPIC IMAGE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY OVERLOADING ON THE DEVICE DURING USAGE WHICH CAUSED SUDDEN BRITTLE FRACTURE. ALSO, SINCE THE DEVICE WAS MANUFACTURED IN 2013, IT IS PLAUSIBLE THAT WEAKENED STRUCTURAL INTEGRITY DUE TO FREQUENT USAGE AND REPROCESSING CYCLES (WEAR AND TEAR) MAY HAVE ALSO CONTRIBUTED TO THE BREAKAGE, THEREFORE IT IS SAFE TO SAY THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED AS THERE IS NO PRIOR COMPLAINT REPORTED WITH THE SAME LOT. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    AS REPORTED: "A SHORT GAMMA3 NAIL WAS REMOVED TO IMPLANT A HIP PROSTHESIS. WHEN REMOVING THE END CAP, THE DISTAL SCREWDRIVER HEAD OF THE INSTRUMENT BROKE OFF. OUR LOANER KIT WAS USED FOR THE EXTRACTION. ANOTHER SET OF INSTRUMENTS HAD TO BE ORDERED FROM ANOTHER HOSPITAL, WHICH RESULTED IN A SURGICAL DELAY OF ALMOST 60 MINUTES." AJ (B)(6) 2023, REP CONFIRMED THAT THE NAIL WAS INTACT AND IT WAS ONLY REMOVED AS PATIENT REQUIRED FULL PROSTHESIS. KT (B)(6) 2023: REP CONFIRMED THAT THE REASON FOR THE CONVERSION WAS A HIP JOINT ARTHROSIS AND THAT THE SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY AFTER GETTING AN ADDITIONAL INSTRUMENT KIT FROM ANOTHER HOSPITAL. REP FURTHER CONFIRMED THAT THE BROKEN TIP OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT AND THAT ALL (THREE) PARTS WERE ALREADY RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    AS REPORTED: "A SHORT GAMMA3 NAIL WAS REMOVED TO IMPLANT A HIP PROSTHESIS. WHEN REMOVING THE END CAP, THE DISTAL SCREWDRIVER HEAD OF THE INSTRUMENT BROKE OFF. OUR LOANER KIT WAS USED FOR THE EXTRACTION. ANOTHER SET OF INSTRUMENTS HAD TO BE ORDERED FROM ANOTHER HOSPITAL, WHICH RESULTED IN A SURGICAL DELAY OF ALMOST 60 MINUTES." ACCORDING TO ADDITIONAL INFORMATION RECEIVED THE REP CONFIRMED THAT THE NAIL WAS INTACT AND IT WAS ONLY REMOVED AS PATIENT REQUIRED FULL PROSTHESIS. FURTHER, THE REP CONFIRMED THAT THE REASON FOR THE CONVERSION WAS A HIP JOINT ARTHROSIS AND THAT THE SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY AFTER GETTING AN ADDITIONAL INSTRUMENT KIT FROM ANOTHER HOSPITAL. THE REP FURTHER CONFIRMED THAT THE BROKEN TIP OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT AND THAT ALL (THREE) PARTS WERE ALREADY RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108280 SPREADING SCREWDRIVER, BALL TIP GAMMA3® 8 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH 1320-0066 K02AD37 04546540487667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown