BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3® 8X35MM

    MDR report key: 5976326 · Received September 26, 2016

    Report

    Report Number
    0009610622-2016-00450
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 29, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE GAMMA3 NAIL HOLDING SCREW (NHS) TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NHS RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR APPROX. 4 YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE PROVIDED NHS SHOW THAT A RIM PART WAS COMPLETELY BROKEN OFF FROM THE HEAD, AROUND THE BROKEN PART DEFORMATIONS AND ABRASIONS WERE VISIBLE INDICATING THAT THE NHS RIM PART WAS HEAVILY IMPACTED USING AN UNKNOWN TOOL LIKE A CHISEL. DUE TO THE IMPACTS THE RIM MATERIAL GOT OVERLOADED AND A PART WAS BROKEN OFF IN A BRITTLE FRACTURE. THE NHS WAS MOST LIKELY IMPACTED TO IMPLANT A NAIL WITH HAMMER BLOWS. HAMMERING THE NHS DIRECTLY IS NOT ALLOWED; THE TARGET DEVICE IS MARKED WITH THE MARKING ¿DO NOT HIT!¿ TO PREVENT DIRECT BLOWS WITH A HAMMER. A NEW TARGET DEVICE WAS DESIGNED (CAT# 13200111), INCLUDING A SLOT FOR THE STRIKE PLATE (CAT# 18060150) TO MAKE NAIL INSERTIONS BY HAMMERING POSSIBLE. THE BROKEN NHS IS RELATED TO AN ABNORMAL USAGE. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY DISCREPANCIES. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT(S). NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE OR MANAGER REPORTED THE FOLLOWING EVENT : "DURING SURGERY, WHEN IMPLANTING A GAMMA NAIL, THE SURGEON TOOK A HAMMER AND THE SCREW BROKE. THE SURGEON HAS TO USE A SECOND DEVICE AVAILABLE IN THE ANCILLARY. NO DEBRIS LEFT INTO THE PATIENT , XRAY PERFORMED TO CHECK AND IT'S OK."

    Description of Event or Problem · 1

    THE OPERATING ROOM MANAGER REPORTED THE FOLLOWING EVENT : " DURING SURGERY, WHEN IMPLANTING A GAMMA NAIL, THE SURGEON TOOK A HAMMER AND THE SCREW BROKE. THE SURGEON HAS TO USE A SECOND DEVICE AVAILABLE IN THE ANCILLARY. NO DEBRIS LEFT INTO THE PATIENT, XRAY PERFORMED TO CHECK AND IT'S OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629414 NAIL HOLDING SCREW GAMMA3® 8X35MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K249668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other