BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/16MM

    MDR report key: 3120591 · Received May 20, 2013

    Report

    Report Number
    2520274-2013-02726
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DESCRIBED SURGICAL PROCEDURE OF A CLAMSHELL APPROACH FOR A BILATERAL LUNG TRANSPLANT IN THE COMPLAINT DESCRIPTION REQUIRES THAT A TRANSVERSE STERNOTOMY BE PERFORMED ON THE INFERIOR PORTION OF THE STERNAL BODY (REFER TO THE INCISION DIAGRAM ILLUSTRATED IN BAINS, MANJIT S., GINSBERG, ROBERT J. ET.AL. (1994) THE CLAMSHELL INCISION: AN IMPROVED APPROACH TO BILATERAL PULMONARY AND MEDIASTINAL TUMOR, THE ANNALS OF THORACIC SURGERY, 1994; 58:30-3). THIS TYPE OF SURGICAL TECHNIQUE IS NOT ILLUSTRATED OR DISCUSSED IN THE TITANIUM STERNAL FIXATION SYSTEM TECHNIQUE GUIDE (J5743-F). THE USE OF THE MANUBRIUM STAR PLATE ON THE STERNAL BODY AS REQUIRED FOR THE INDICATED PROCEDURE DOES NOT FOLLOW THE SPECIFIED ANATOMICAL PLACEMENT OF THE PLATE; STEP 14 OF THE TECHNIQUE GUIDE SPECIFIES THAT A PLATE CAN BE PLACED ON THE MANUBRIUM FOR EXTRA SUPPORT, IF NEEDED, SEVERAL STAR-SHAPED AND H-SHAPED PLATES ARE AVAILABLE FOR PLACEMENT ON THE MANUBRIUM. THE H-SHAPED AND STAR-SHAPED PLATES ARE INTENDED ONLY FOR USE ON THE MANUBRIUM, (PG15). IN ADDITION, THE USE OF ONE PLATE WITHOUT ADDITIONAL SUPPORTING PLATES OR SURGICAL WIRES IS NOT ONE OF THE RECOMMENDED COMBINATIONS INDICATED PER STEP 13 OF THE TECHNIQUE GUIDE (PG15). THE PLATE DOES NOT APPEAR TO HAVE BEEN CONTOURED TO MATCH THE BONY ANATOMY WHICH IS IN AGREEMENT WITH THE COMPLAINT DESCRIPTION THAT STATES: IT WAS REPORTED THAT THE BOTTOM PART OF THE PLATE MAY NOT HAVE BEEN CONTOURED PROPERLY, BUT THE SHAPE OF THE STERNUM IS UNKNOWN WITHOUT SUPPORT CLINICAL IMAGING. NOT APPROPRIATELY CONTOURING THE PLATE TO THE BONY ANATOMY CAN AFFECT THE PERFORMANCE OF THE DEVICE IN RELATION TO THE USE OF THE ADEQUATE SCREW LENGTH AND BIOMECHANICAL LOADING OF THE DEVICE. WHEN LOCKING SCREWS ARE USED AND ARE FULLY SEATED INTO A STERNAL PLATE, THE LOCKING THREADS ON THE HEAD OF THE SCREW WILL PLASTICALLY DEFORM AND BE EVIDENT UPON REMOVAL. EIGHT (8) OF THE LOCKING SCREWS RETURNED APPEAR TO HAVE BEEN FULLY SEATED INTO THE STAR PLATE AS INDICATED BY THE DEFORMATION OF THE LOCKING THREADS ON THE HEAD OF THE SCREW. FOUR (4) OF THE LOCKING SCREWS APPEAR TO NOT HAVE BEEN FULLY LOCKED IN THE STAR PLATE BECAUSE THERE IS NO NOTICEABLE DEFORMATION OF THE LOCKING THREADS. ALL THREAD DEFORMATION WAS VIEWED UNDER 10X MAGNIFICATION. IF SCREWS ARE NOT FULLY LOCKED IN THE PLATE THERE IS AN INCREASED CHANCE THAT THE SCREWS WILL LOOSEN AND PARTIALLY AND/OR FULLY MIGRATE OUT OF THE BONE. THE QUALITY OF THE BONE IN RELATION TO THE PLACEMENT OF THE PLATE IS UNKNOWN. THE CAUSE OF THE NOTED SCREW PULLOUT IS NOT CLEAR. THE DESIGN AND CLINICAL RISK ASSESSMENT FOR THE TITANIUM STERNAL FIXATION SYSTEM (WINDCHILL # 0000053299, A.26) DOES ADEQUATELY ADDRESS THE HAZARD OF SCREW LOOSENING WITH A SEVERITY OF HARM OF 4 (MAJOR) AND A RATE OF OCCURRENCE OF 1 (NEGLIGIBLE) RESULTING IN A LESS SEVERE RISK. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT'S INITIAL SURGERY ON(B)(6) 2013, WAS FOR A BILATERAL LUNG TRANSPLANT/CLAM SHELL APPROACH (PERICOSTALS (ALL), INFERIOR PLATE OUT OF ANTERIOR STERNAL TABLE). PATIENT WAS IMPLANTED WITH A STERNAL LOCKING STAR PLATE AND 12 STERNAL LOCKING SCREWS. THE PLACEMENT OF THE PLATE AND SCREWS LOOKED GOOD, PATIENT WAS SUTURED WITH DEEP AND SOFT TISSUE SUTURES. PROCEDURE WAS COMPLETED. PATIENT EXPERIENCED SOME FORM OF DISCOMFORT/PAIN AND RETURNED TO THE SURGEON ON (B)(6) 2013. IT WAS NOTED THAT THE INCISION ON THE CHEST WAS NOT ALIGNED AND WAS OPEN. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013, FOR REVISION SURGERY. THE SURGEON OPENED THE ENTIRE INCISION. THE PATIENT HAD NOT HEALED AND THE STERNUM HAD OPENED AND WAS UNSTABLE. SIX SCREWS ON THE TOP PORTION OF THE STERNUM WERE STILL LOCKED INTO THE PLATE AND BONE. THE OTHER SIX SCREWS ON THE BOTTOM PORTION OF THE STERNUM HAD PULLED OUT AND WERE NO LONGER LOCKED INTO THE PLATE OR BONE. THE SUTURES WERE NOT INTACT. IT WAS REPORTED THAT THE BOTTOM PART OF THE PLATE MAY NOT HAVE BEEN CONTOURED PROPERLY, WHICH MAY HAVE CAUSED ALL OF THE LOAD TO BE PLACED ON THE BOTTOM PART OF THE PLATE. THE PLATE AND SCREW CONSTRUCT WAS REMOVED AND REPLACED. SURGEON IMPLANTED TWO NEW CONTOURED PLATES AND ABOUT 23-24 SCREWS AND PERFORMED WOUND DEBRIDEMENT. THE PATIENT WAS RE-SUTURED WITH DEEP AND SOFT TISSUE SUTURES. THIS IS 4 OF 13 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221960 3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/16MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention