BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL SPHERE INSTRUMENT SET

    MDR report key: 8443861 · Received March 22, 2019

    Report

    Report Number
    3005180920-2019-00186
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630030877414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 MARCH 2019: LOT 1810892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2024-01-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CONSIDERING THE (B)(4), NO OTHER SIMILAR EVENT HAS EVER BEEN REPORTED. ADDITIONAL COMPONENT THAT BROKE OFF DURING SURGERY: GMK SPHERE INSERT SET I5L-T5 REF 11.01025 (LOT 1812071): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2023-12-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CONSIDERING THE (B)(4), NO OTHER SIMILAR EVENT HAS EVER BEEN REPORTED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: ACCORDING TO WHAT REPORTED BY THE SURGEON, THE CAUSE OF THE IMPACTOR BREAKAGE WAS PROBABLY DUE TO A VERY HARD BONE; IN THIS SITUATION, THE SURGEON PROBABLY NEEDED TO APPLY EXCESSIVE FORCE DURING IMPACTIONS WITH ALSO THE RISK OF MISALIGNMENT DURING THE KEEL PREPARATION. THE HANDLE IS INTENDED TO BE IMPACTED IN ITS LONG AXIS. IMPROPER IMPACTION DIRECTION CAN OVERLOAD THE CONNECTION WITH A BENDING STRESS WITH THE CONSEQUENT RISK OF BREAKAGE OF THE HANDLE-TIP. THE POSSIBILITY TO IMMEDIATELY USE A NEW SET IN CASE OF PROBLEM, IS ONE OF THE KEY POINT OF THE EFFICIENCY INSTRUMENTATION; THE NEW DEVICE ALLOWED TO CORRECTLY REMOVE THE KEEL PUNCHER AND CONCLUDE THE SURGERY. IN CASE OF INSTRUMENT BREAKAGE OR EVEN JUST IN CASE OF ACCIDENTAL FALL OF THE INSTRUMENT, THE BEST SOLUTION IS ALWAYS TO OPEN A NEW SET INSTEAD OF TRYING TO PROCEED WITH INAPPROPRIATE TOOLS AS DONE DURING THE SURGERY.

    Description of Event or Problem · 1

    DURING PRIMARY TKA THE TIP OF THE IMPACTOR HANDLE BROKE AND IT WAS IMPOSSIBLE TO GET THE TRIAL KEEL OUT OF THE PATIENT. AFTER SOME ATTEMPTS A METAL CHISEL WAS USED TO GET IT OUT. ALSO IN THIS CASE IT WAS IMPOSSIBLE TO REMOVE THE TRIAL KEEL, THAT BROKE OFF, TOO. THEY WERE FORCED TO OPEN A NEW GMK EFFICIENCY KIT AND USE THE NEW IMPACTOR HANDLE SUCCESSFULLY. THE BONE WAS VERY HARD DUE TO A TIBIA OSTEOTOMY CARRIED OUT SOME YEARS AGO BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235562 GENERAL SPHERE INSTRUMENT SET SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 1810892 07630030877414

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other