BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK EFFICIENCY THREADED PIN Ø3.2 L70 HA3.5 MECHE TRIANGLE

    MDR report key: 12982546 · Received December 13, 2021

    Report

    Report Number
    3005180920-2021-00971
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    February 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630030842740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE VISUAL INSPECTION CONFIRMED THE PRELIMINARY INVESTIGATION : " THE PIN LOOKS BENDED WITH SIGNS OF DAMAGE PROBABLY GENERATE WHEN TRYING TO REMOVE THE PIN STUCK IN THE CUT GUIDE. ALSO THE TIP OF THE PIN LOOKS DAMAGED AS WELL AS THE THREADED PART. WE COULD IMAGINE THAT DURING INSERTION, THE PIN WAS FORCED AGAINST THE HOLE OF THE CUTTING GUIDE; THE HEAT GENERATED DURING THE FRICTION COULD HAVE GENERATED COLD WELDING OF THE PIN ON THE GUIDE AND THE CONSEQUENT BREAKAGE OF THE TIP OF THE PIN.". NO ADDITIONAL INFORMATION DETECTED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 DECEMBER 2021. REFERENCE 11.00009 LONG THREADED PINS LOT 2113716. LOT 2113716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2021. EXPIRATION DATE: 2026-09-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. THREADED PIN Ø3.2 L70 HA3.5 MECHE TRIANGLE LOT. MAT34617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. PRELIMINARY INVESTIGATION: THE IMAGES OF THE COMPLAINT SHOW THE BREAKAGE OF THE TRIANGULAR MOTORIZED CONNECTION OF THE PIN. THE PIN LOOKS BENDED WITH SIGNS OF DAMAGE PROBABLY GENERATED WHEN TRYING TO REMOVE THE PIN STUCK IN THE CUTTING GUIDE. ALSO THE TIP OF THE PIN LOOKS DAMAGED AS WELL AS THE THREADED PART. WE COULD IMAGINE THAT DURING INSERTION, THE PIN WAS FORCED AGAINST THE HOLE OF THE CUTTING GUIDE; THE HEAT GENERATED DURING THE FRICTION COULD HAVE GENERATED COLD WELDING OF THE PIN ON THE GUIDE AND THE CONSEQUENT BREAKAGE OF THE TIP OF THE PIN. MORE SPECIFIC INFORMATION RELATING TO THE CAUSE OF THE COMPLAINT CAN BE OBTAINED DURING THE VISUAL INSPECTION.

    Description of Event or Problem · 0

    WHEN THE PIN WAS INSERTED TO FIX THE CUTTING BLOCK IT BROKE AT THE CONNECTION LEVEL WITH THE PIN ADAPTER. THE SURGEON USED A BACKUP CUTTING BLOCK AND PIN AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880077 GMK EFFICIENCY THREADED PIN Ø3.2 L70 HA3.5 MECHE TRIANGLE IINSTRUMENT THREADED PIN LXH MEDACTA INTERNATIONAL SA 11.00009 2113716 07630030842740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other