BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    MDR report key: 4973310 · Received August 5, 2015

    Report

    Report Number
    1000562954-2015-10163
    Event Type
    Injury
    Date Received
    August 5, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DEVIATION FROM THE SPECIFICATIONS COULD BE DETECTED. AS STATED IN THE ADDITIONAL INFORMATION SECTION OF THE COMPLAINT THERE IS NO ALLEGATION AGAINST THE CORTEX SCREWS, THE COMPLAINT IS ABOUT THE BROKEN LOCKING SCREWS. ALSO THERE IS NO LOOSENING OF A CORTEX SCREW VISIBLE ON THE RECEIVED X-RAYS, ONLY THE HEAD OF A LOCKING SCREW SEEMS TO BE LOOSE, WHICH CAN BE TRACED BACK TO THE FRACTURE OF THE HEAD. THEREFORE ONLY A VISUAL INSPECTION HAS BEEN PERFORMED. THE THREADS OFF ALL SCREWS ARE IN AN EXCELLENT CONDITION, NO DAMAGES OR WEAR MARKS VISIBLE. AT THE STARDRIVE RECESSES ARE SOME STRESS MARKS VISIBLE, WHICH CAN BE TRACED BACK TO SCREWDRIVER CONTACT, EITHER DURING INSERTION OR EXTRACTION. AT THE BOTTOM SIDE OF THE HEADS ARE SLIGHT STRESS MARKS VISIBLE, WHICH INDICATES A PROPER CONTACT BETWEEN THE SCREW HEAD AND THE PLATE DURING TIGHTENING. THERE IS NO INDICATION OF ANY FAULT AT THE CORTEX SCREWS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT WAS NOT PROVIDED BY REPORTER. IT IS UNCLEAR TO SYNTHES AT THIS TIME IF THIS DEVICE WAS ONE OF THE SCREWS WHICH HAD LOOSENED AND/OR HAD BROKEN THEN LOOSENED POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT A RESPONSE HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT. DATE OF IMPLANT WAS NOT PROVIDED BY REPORTER BUT WAS REPORTED AS APPROXIMATELY 3 MONTHS PRIOR TO (B)(6) 2015. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL INFORMATION PROVIDED. EFFORTS ARE CURRENTLY BEING MADE REQUEST CLARIFICATION REGARDING HCP STATEMENT OF DEVICE LOOSENING. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO UNKNOWN LOCKING SCREWS BROKE AT THE HEAD OR LOOSENED FROM THE SHAFT APPROXIMATELY THREE (3) MONTHS POSTOPERATIVELY. THE DATE OF IMPLANT IS UNKNOWN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015, AND A 2.4MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) VOLAR DISTAL RADIUS PLATE, TWO 2.7MM CORTEX SCREWS, AND FOUR UNKNOWN SCREWS (INCLUDING TWO UNKNOWN LOCKING SCREWS WHICH REPORTEDLY BROKE OR LOOSENED AND TWO UNKNOWN CORTEX SCREWS) WERE EXPLANTED FROM THE PATIENT. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PROVIDED X-RAYS WERE REVIEWED BY A DEPUY SYNTHES MEDICAL DIRECTOR WHO CONFIRMED THE DEVICE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513349 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM SCREW, FIXATION, BONE HWC SYNTHES MEZZOVICO 8369016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention