BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HANDLE, REVOLVING/RIGID, MANDIBULAR FRACTURE AND RECONSTRUCTION SYST

    MDR report key: 6080485 · Received November 4, 2016

    Report

    Report Number
    0008010177-2016-00263
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 11, 2016
    Report Date
    December 27, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT ¿THE SCREW OF THE SCREWDRIVER HANDLE PEELED AWAY AND THE HANDLE GOT LOOSE¿ COULD BE CONFIRMED. THE VISUAL INSPECTION OF THE RETURNED SCREWDRIVER REVEALED THAT ON BOTH SIDES OF THE GRIP FRONT PART EACH FIXING SCREW HAS BEEN DETACHED. ALSO THE FIXING SCREW FOR THE GRIP BACK PART IS MISSING. ALL THREE DETACHED SCREWS WERE NOT RETURNED. FURTHERMORE, THE RETURNED SCREWDRIVER HANDLE IS MARKED WITH PRODUCTION CODE # X1 WHICH INDICATES THAT THE DEVICE WAS MANUFACTURED IN 2007-JAN. MOREOVER, EACH COUNTERSINK OF THE SCREW HOLES OF THE DETACHED SCREWS SHOW CLEAR FRICTION TRACES ¿ MATERIAL INDENTATIONS INDICATING THAT ALL THREE SCREWS WERE INITIALLY ATTACHED AND FIRMLY TIGHTENED. GENERALLY, A SCREW LOOSENING OF ITSELF IS VERY IMPLAUSIBLY ¿ ESPECIALLY IN THIS CASE CONSIDERING THE CLEAR AND DEEP INDENTATIONS IN EACH COUNTERSINK OF THE SCREW HOLES. ADDITIONALLY, WITHIN THE ASSEMBLY OF THE SCREWDRIVER HANDLE A 100% SELF WORKER CONTROL TAKES PLACE AND FOR THE FIXATION OF THE SCREWS ADEQUATE SCREWDRIVER BLADES ARE BEING USED WHICH DO FIT TO THE SIZE OF THE SCREW SLOTS AND THEREFORE DURING THE SCREW FIXATION APPROPRIATE TIGHTENING FORCES CAN BE APPLIED WITHIN THE ASSEMBLY STEP. THE RETURNED SCREWDRIVER HANDLE WAS MANUFACTURED IN 2007-JAN. THE LONG TIME-USE OVER 10 YEARS DOES NOT POINT TO ANY MANUFACTURING AND /OR MATERIAL RELATED ISSUE. POTENTIALLY THE USER OR CUSTOMER WANTED TO DISASSEMBLE THE SCREWDRIVER HANDLE BECAUSE IT IS VERY IMPLAUSIBLY THAT THREE SCREWS HAS BEEN DETACHED AT THE SAME TIME. FURTHERMORE, IN THE PLASTIC MATERIAL AROUND THE SCREW HOLE OF THE GRIP BACK PART SEVERAL DEEP SCRATCHES ARE VISIBLE RESULTING FROM SLIPPING OF THE SCREWDRIVER BLADE OUT OF THE SLOT OF THE INITIALLY MOUNTED FIXING SCREW. THESE DEEP SCRATCHES IN THE PLASTIC MATERIAL DEFINITIVELY DO NOT ORIGINATE FROM THE ASSEMBLY WITHIN THE MANUFACTURING BUT THE SCRATCHES ARE A FURTHER INDICATION FOR DISASSEMBLY OF THE SCREW PERFORMED BY THE USER OR CUSTOMER THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FOR CERTAIN BUT ACCORDING TO THE DETERMINATIONS WITHIN THE VISUAL INVESTIGATION USING THE MICROSCOPE AND CONSIDERING ALL LISTED FACTS THE ROOT CAUSE COULD BE MOST LIKELY ATTRIBUTED TO A USER RELATED ISSUE. CONCERNING THE SCREW DETACHMENT OF THE GRIP FRONT PART CAPA # (B)(4) WAS PREVIOUSLY RAISED AS A PREVENTIVE ACTION IN ORDER TO SECURE THE SCREW WITH A WELDING POINT AND TO INDICATE AND TO AVOID A SCREW DISASSEMBLING BY THE USER. FIRST PARTS WERE MANUFACTURED IN 2011-DEC AND AFTER THE EFFECTIVENESS CHECK THE CAPA WAS CLOSED ON 2012-JUN-19. THEREFORE THE RETURNED DEVICE WAS IDENTIFIED AS A FORMER DESIGN. INDICATIONS FOR ANY PRODUCT RELATED PROBLEMS WERE NOT FOUND IN THE INVESTIGATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR FURTHER ADVERSE TRENDS

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE AT THE USER FACILITY THAT A SCREW FROM THE SCREWDRIVER HANDLE HAD BECOME DISENGAGED FROM THE THREADS DURING PRODUCT STERILIZATION. THERE WERE NO ADVERSE CONSEQUENCES, DELAY IN SURGERY, OR MEDICAL INTERVENTION IN RESULT OF THIS ALLEGED PRODUCT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE AT THE USER FACILITY THAT A SCREW FROM THE SCREWDRIVER HANDLE HAD BECOME DISENGAGED FROM THE THREADS DURING PRODUCT STERILIZATION. THERE WERE NO ADVERSE CONSEQUENCES, DELAY IN SURGERY, OR MEDICAL INTERVENTION IN RESULT OF THIS ALLEGED PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731524 SCREWDRIVER HANDLE, REVOLVING/RIGID, MANDIBULAR FRACTURE AND RECONSTRUCTION SYST INSTRUMENT LXH STRYKER LEIBINGER FREIBURG X1 - 01/2007

    Patients

    Seq Age Sex Outcome Treatment
    1