BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® LAG SCREW

    MDR report key: 2864215 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03634
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    July 10, 2010
    Report Date
    July 23, 2010
    Manufacturer
    SYNTHES
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED PLATE DID NOT FIT OVER THE SCREW. PATIENT HAD MINIMALLY DISPLACED GARDEN 1 OR 2 INTRACAPSULAR FRACTURED NECK OF RIGHT FEMUR. SPINAL ANESTHETIC. NO REDUCTION REQUIRED GOOD POSITION ON FRACTURE TABLE. PREPPED AND DRAPED AS ROUTINE WITH STANDARD LATERAL APPROACH TO PROXIMAL FEMUR. GUIDE WIRE WAS INSERTED. GOOD POSITION 2ND PASS. MEASURED 100MM, TIP OF WIRE IN SUBCHONDRAL BONE. REAMED TO 100MM, VIEWED IT ON II. ALMOST FULL LENGTH OF WIRE TAPPED. A 100MM SCREW FROM SET INSERTED AND PLACED WITHOUT DIFFICULTY. DEROTATION WIRE IN SUPERIOR ASPECT OF NECK / HEAD DURING REAMING/TAPPING/INSERTION OF LAG SCREW, THEN REMOVED. ALL PERFORMED WITH NO PROBLEMS UNTIL NOW. THERE WAS ONLY ONE 2-HOLE PLATE, 135 DEGREES ON SET. RETRACTED SOFT TISSUE AND TRIED TO PUT PLATE ON LAG SCREW. LAG SCREW INSERTER WAS PARALLEL WITH FEMUR WHEN SCREW INSERTED. PLATE WOULD NOT ADVANCE ONTO SCREW. WE TRIED GENTLE PERSUASION, DIFFERENT ORIENTATION OF PLATE ONTO SCREW, GENTLE HAMMERING. NONE OF THIS WORKED. MR. (B)(6) WAS CALLED INTO THE THEATRE TO SCRUB. HE TRIED ALL THAT I HAD TRIED AGAIN. IN ADDITION HE TRIED OTHER PLATES ON THE SET, PLUS PLATES ON A SECOND SET SUBSEQUENTLY OPENED. IT BECAME CLEAR THAT NO PLATE WOULD FIT THE SCREW. THERE APPEARED TO BE SOME INCOMPATIBILITY BETWEEN SCREWS AND PLATES IN GENERAL ALTHOUGH WE DIDN'T SYSTEMATICALLY CHECK THEM ALL. THE DECISION WAS THEN TAKEN TO TRY AND REMOVE THE SCREW AND IF POSSIBLE RE-DO THE FIXATION. THE SCREW INTRODUCER WOULD TURN THE SCREW BUT NOT WITHDRAW IT. IT WAS THEN SPINNING WITHOUT WITHDRAWING. WE THEN HAD TO TRY AND GET TRACTION ON THE END OF THE SCREW USING PLIERS, MOLE WRENCH AND DEVICES FROM THE SCREW REMOVAL SET. NOTHING WAS EFFECTIVE. THE FRACTURE WAS NOW SIGNIFICANTLY DISPLACED, GARDEN 3-4. THROUGH THE STANDARD INCISION FOR A DYNAMIC HIP SYSTEM, WE WERE UNABLE TO PLACE A PLATE ON THE LAG SCREW TO REMOVE IT AND THEREFORE THE DECISION TO CONVERT TO ARTHROPLASTY WAS MADE. AS THIS LADY WAS INDEPENDENTLY MOBILE AND FIT AND WELL PRIOR TO HER MECHANICAL FALL, TOTAL HIP REPLACEMENT WAS MOST APPROPRIATE. THIS WAS THOUGHT BEST TO BE DONE ON A WEEKDAY ELECTIVE, THEATRE LIST WITH STAFF FAMILIAR WITH THE THR KIT, AND TO ENSURE AVAILABILITY OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS®/DCS® LAG SCREW DHS®/DCS® LAG SCREW KTT SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DHS/DCS LAG SCREW 12.7MM THREAD/100MM