BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø3.5 L32 TI

    MDR report key: 3192504 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03415
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE ADDITIONAL EVALUATION REVEALED THAT THE FAILURE OF THE CORTEX SCREWS OCCURRED BELOW THE SCREW HEAD IN THE THREADED PART OF THE SCREW SHAFT. AFTER BREAKING, THE SCREW FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING SOME DESTRUCTION OF THE FRACTURE SURFACES. WHEN EXAMINING THE FRACTURE SURFACES OF THE SCREW HEAD FRAGMENTS (A, B, C, AND D) USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR COULD BE IDENTIFIED. ALL CORTEX SCREWS SHOW CHARACTERISTICS OF ALTERNATING BENDING LOADS. PATTERNS OF RIPPLES OR FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT. THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE EXAMINATION OF THE FRACTURE SURFACES INDICATE THAT THE SCREWS (A, B, C, D) FAILED BECAUSE OF FATIGUE AND OVERLOAD (TWO-SIDED BENDING). THE TOPOGRAPHY OF THE FRACTURE SURFACES ARE CHARACTERIZED BY A MIXED FRACTURE WITH FATIGUE STRIATIONS AND A STRUCTURAL APPEARANCE. STRUCTURAL BREAKAGE APPEARANCE IS TYPICAL FOR PURE TITANIUM AND INDICATES TEMPORARY HIGH LOADS (STRESS PEAKS). SEM OBSERVATIONS AND FINDINGS INDICATE THAT THE PLATE FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD (TWO-SIDED BENDING). A DISTAL TIBIA AND FIBULA BONE FRACTURE WAS STABILIZED BY MEANS OF AN 8 HOLE LCP PLATE AND A 9 HOLE ONE THIRD TUBULAR PLATE. THE BROKEN CORTEX SCREWS WERE USED WITH THE LCP PLATE. THERE WAS NO FURTHER INFORMATION AVAILABLE. THE DEVICE REPORT DID NOT INCLUDE ANY COMMENTS ON THE POSTOPERATIVE OUTCOME. THERE WAS NO REPORT WITH RESPECT TO THE AFTERCARE OF THE PATIENT. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES OF THE CORTEX SCREWS WE ASSUME THAT THE SCREWS BROKE BECAUSE OF FATIGUE AND OVERLOAD. WE FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TRAFFIC ACCIDENT WITH DISTAL TIBIA AND FIBULA FRACTURE. THE TIBIA FRACTURE WAS TREATED BY MEANS OF AN LCP PLATE WITH EIGHT HOLES AND CORTICAL SCREWS. THE FIBULA FRACTURE WAS TREATED BY MEANS OF A THIRD TUBULAR PLATE WITH NINE HOLES AND CORTICAL SCREWS. SCREW BREAKAGE WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4); RELATED COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR TWO 404.032 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293516 CORTSCR Ø3.5 L32 TI HWC SYNTHES GMBH 3250730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention