BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 85MM

    MDR report key: 4722862 · Received April 23, 2015

    Report

    Report Number
    2520274-2015-13356
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    April 8, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 29. JAN 2013, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT: UNKNOWN. DATE OF EXPLANT: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: PART 414.885, LOT 8152809: THE GOLDEN ANODIZED SCREWS ARE MADE OF PURE TITANIUM. THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEET OF THE SUPPLIER AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE DIMENSIONS OF THE INVESTIGATED SCREW (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALLIPER AND FOUND NOT TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND SPECIFICATIONS. THE SCREW WAS RECEIVED WITHOUT THE TIP. THE SCREW SHOWED MECHANICAL DAMAGES. THE ORIGINS OF THESE MECHANICAL DAMAGES ARE UNKNOWN AND CANNOT BE RECONSTRUCTED BECAUSE OF THE LITTLE INFORMATION WE RECEIVED. WHEN EXAMINING THE FRACTURE SURFACES OF THE SCREW USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE AREAS OF FRACTURE INITIATION AND THE FRACTURE BEHAVIOR COULD BE IDENTIFIED. THE SCREW SHOWED A PRIMARY AND A SECONDARY CRACK INITIATION ZONE. THE CRACKS STARTED AT THE OUTER SURFACE OF THE SCREWS AND RAN INTO THE MATERIAL. AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND ALMOST OVER THE ENTIRE FRACTURE SURFACES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT AND THEY ORIGINATE FROM CYCLIC LOADS. THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE FRACTURE SURFACES SHOWED ALSO A STRUCTURED BREAKAGE (CRYSTALLOGRAPHIC ORIENTED FATIGUE FRACTURE) OR A MIXED FRACTURE. STRUCTURED BREAKAGE IS TYPICAL FOR A FATIGUE FRACTURE IN PURE TITANIUM AND INDICATES MODERATE LOADS. THE AREA WITH DIMPLES CORRESPONDS TO THE (RESIDUAL) FORCED FRACTURE ZONE. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE SCREW FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD. BASED ON THE SEM EXAMINATION OF THE SCREW, WE CAN CONCLUDE THAT THESE SCREWS WERE SUBJECTED TO MODERATE DYNAMIC BENDING LOADS (TWO SIDED). CONSTANTLY ALTERNATING LOAD CYCLES (DURING MOVEMENT) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE SCREW. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM A MATERIAL DEFECT OF THE SCREWS CAN BE EXCLUDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PREVIOUS SURGERY ON (B)(6) 2015, THE SURGEON PLACED TEN 4.5 MM CORTEX SCREW. DURING A SECOND SURGERY SURGEON REMOVED FIVE SCREWS BECAUSE THEY WERE BROKEN. THE PATIENT STATUS IS REPORTED AS OKAY. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269133 4.5MM TI CORTEX SCREW SELF-TAPPING 85MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 8152809

    Patients

    Seq Age Sex Outcome Treatment
    1