BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3 8X35MM

    MDR report key: 10496895 · Received September 4, 2020

    Report

    Report Number
    0009610622-2020-00497
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 11, 2020
    Report Date
    December 2, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS/UPDATES WERE MADE TO SECTION D. 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 ASSEMBLY OF DEVICES COULDN¿T BE DISASSEMBLED AS THE NAIL HOLDING SCREW WAS FOUND TO BE STUCK WHICH CONFIRMS THE EVENT. THERE ARE SOME DAMAGE MARKS ON THE DISTAL HOLE OF THE NAIL (CONCOMITANT DEVICE). AN EFFORT WAS MADE TO DETACH THE NAIL AND UNSCREW THE NAIL HOLDING SCREW TO RELEASE THE NAIL, BUT IT IS IMPOSSIBLE TO DETACH THE ASSEMBLY WHICH CONFIRMS THE STATED EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE RETURNED AFFECTED DEVICE COULD NOT BE DISASSEMBLED, AND THE LOT NUMBER WAS NOT AVAILABLE. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE INSTRUCTIONS FOR USE STATES: ¿DO NOT HIT INSTRUMENTS UNLESS THEY ARE SPECIFICALLY INTENDED FOR IMPACTION. NEVER HIT TARGETING DEVICES OR ELASTOSIL HANDLES OTHER THAN THOSE WITH AN INTEGRATED STRIKE PLATE. ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE GEOMETRY. THE STRYKER "INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE" HELP TO DETERMINE WHETHER AN INSTRUMENT IS IN GOOD CONDITION OR MUST BE REPLACED DUE TO EXCESSIVE WEAR OR OBVIOUS DEFECTS. DURING THE PROCEDURE, REPEATEDLY CHECK THAT THE CONNECTIONS BETWEEN THE INSTRUMENTS OR BETWEEN IMPLANTS AND INSTRUMENTS REQUIRED FOR THE PRECISE POSITIONING AND FIXING ARE SECURE.¿ BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED DUE TO HANDLING FAILURE (E.G. NAIL HOLDING SCREW IS SCREWED IN TOO TIGHT DURING INSERTION AND SCREW IS FRETTED IN THREAD OF NAIL). IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    AS REPORTED: "LONG G3 OPR. UNABLE TO LOOSEN NAIL HOLDING SCREW FROM NAIL AFTER IMPLANTING NAIL. TOOK OUT RIVETS, UNPACKED OTHER INSTRUMENTATION AND RIVETS AND CONTINUED OPR. "THE OPERATION WAS ALMOST FINISHED, BUT WHEN THEY HAD TO RELEASE THE NAIL FROM THE SIGHT ARM, THIS DID NOT WORK. TOOK EVERYTHING OUT AND USED A NEW GAMMA INSTRUMENT AND A NEW NAIL. IT WENT WELL. OPERATING TIME WAS EXTENDED." "SURGEON HE HAD IMPLANTED THE LONG NAIL AND WAS SUPPOSED TO RELEASE THE NAIL HOLDING BOLT AND REMOVE THE TARGET DEVICE, NAIL HOLDING SCREW WAS LOCKED INTO THE NAIL. HE HAD TO REMOVE NAIL/TARGET DEVICE IN ONE PIECE AND OPEN A NEW INSTRUMENT SET/NAIL AND CONTINUE SURGERY. THEY TRIED TO RELEASE THE NAIL HOLDING BOLT AFTER REMOVED IMPLANT FROM PATIENT, BUT IT WAS IMPOSSIBLE WITHOUT DESTROYING THEIR SCREWDRIVER HANDLE."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED: "LONG G3 OPR. UNABLE TO LOOSEN NAIL HOLDING SCREW FROM NAIL AFTER IMPLANTING NAIL. TOOK OUT RIVETS, UNPACKED OTHER INSTRUMENTATION AND RIVETS AND CONTINUED OPR. "THE OPERATION WAS ALMOST FINISHED, BUT WHEN THEY HAD TO RELEASE THE NAIL FROM THE SIGHT ARM, THIS DID NOT WORK. TOOK EVERYTHING OUT AND USED A NEW GAMMA INSTRUMENT AND A NEW NAIL. IT WENT WELL. OPERATING TIME WAS EXTENDED." "SURGEON HE HAD IMPLANTED THE LONG NAIL AND WAS SUPPOSED TO RELEASE THE NAIL HOLDING BOLT AND REMOVE THE TARGET DEVICE, NAIL HOLDING SCREW WAS LOCKED INTO THE NAIL. HE HAD TO REMOVE NAIL/TARGET DEVICE IN ONE PIECE AND OPEN A NEW INSTRUMENT SET/NAIL AND CONTINUE SURGERY. THEY TRIED TO RELEASE THE NAIL HOLDING BOLT AFTER REMOVED IMPLANT FROM PATIENT, BUT IT WAS IMPOSSIBLE WITHOUT DESTROYING THEIR SCREWDRIVER HANDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956928 NAIL HOLDING SCREW GAMMA3 8X35MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR