BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER / DEPTH GAUGE 2 IN 1 AUTOFIX 2.0/2.5, 10-30MM

    MDR report key: 6146249 · Received December 5, 2016

    Report

    Report Number
    0008031020-2016-00587
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 17, 2016
    Report Date
    April 26, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 REPORTED EVENT THAT THE TIP OF A SCREWDRIVER / DEPTH GAUGE 2 IN 1 AUTOFIX 2.0/2.5, 10-30MM BROKE DURING SURGERY COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE MOST LIKELY CAUSE IS THAT EXCESSIVE TORQUE WAS APPLIED DURING SCREWING. IN ADDITION TO THIS, ALSO THE FOLLOWING FACTORS MIGHT HAVE CONTRIBUTED TO THE EVENT: - THE INSTRUMENT WAS NOT EXAMINED FOR WEAR AND TEAR BEFORE SURGERY. THE DEVICE HAD EXPERIENCED EXCESSIVE USE OR FORCE AND BECAME SUSCEPTIBLE TO BREAKAGE. - HARD/DENSE BONE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEVICE WAS RECEIVED WITH BROKEN TIP. NO FRAGMENTS HAVE BEEN PROVIDED. THE HELICAL TREND OF THE BREAKAGE IS TYPICAL OF OVERTORQUE. THE FRACTURE BREAKAGE WAS ANALYZED. MOST OF IT PRESENTS THE PATTERN OF INSTANTANEOUS ZONE (UNIFORM FINE GRAINED TEXTURE), REPRESENTING THE FINAL FRACTURE ZONE (OVERLOAD FRACTURE). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT WAS PERFORMED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING THE TREATMENT FOR A BROKEN SCAPHOID. INSERTED THE GW INTO BROKEN BONE AREA AND MEASURED A SCREW LENGTH BY THE DEPTH GAUGE WITH DRIVER. THE TIP OF THE DRIVER BROKE DURING INSERTION OF THE SCREW. THE BROKEN PART WAS REMOVED UNDER X RAY. REMOVED THE GW AND INSERTED THE SCREW BY DRIVER SHAFT FOR REMOVING, AND COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    DURING THE TREATMENT FOR A BROKEN SCAPHOID. INSERTED THE GW INTO BROKEN BONE AREA AND MEASURED A SCREW LENGTH BY THE DEPTH GAUGE WITH DRIVER. THE TIP OF THE DRIVER BROKE DURING INSERTION OF THE SCREW. THE BROKEN PART WAS REMOVED UNDER X RAY. REMOVED THE GW AND INSERTED THE SCREW BY DRIVER SHAFT FOR REMOVING, AND COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794897 SCREWDRIVER / DEPTH GAUGE 2 IN 1 AUTOFIX 2.0/2.5, 10-30MM INSTRUMENT LXH STRYKER GMBH 77178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other