BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 48MM

    MDR report key: 7980283 · Received October 18, 2018

    Report

    Report Number
    8030965-2018-57412
    Event Type
    Injury
    Date Received
    October 18, 2018
    Report Date
    October 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819125117
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PART: 412.218; LOT: L132681; MANUFACTURING SITE: MEZZOVICO; RELEASE TO WAREHOUSE DATE: SEPTEMBER 16, 2016 THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE IMPLANT WAS RECEIVED WITH THE REPORTED CONDITION OF ¿NO REPORTED PRODUCT PROBLEM ADVERSE EVENT: NR THE FOLLOWING INVESTIGATION FLOW WAS PERFORMED: ADVERSE VENT (NO REPORTED PRODUCT PROBLEM) IT WAS VISUALLY OBSERVED THAT THE RETURNED DEVICE SHOWS SURFACE SCRATCHING AND THREAD WEAR CONSISTENT WITH IMPLANT AND SUBSEQUENT EXPLANT. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE TO TREAT AN UNCONSOLIDATED FRACTURE. OSTEOMYELITIS WAS REPORTED DUE TO A 14-HOLE WIDE STRAIGHT LOCKING COMPRESSION PLATE (LCP) THAT WAS BROKEN INTO TWO PARTS. A DEFORMITY OF THE LIMB WAS NOTICED BY THE SURGEON THAT PROMPTED AN X-RAY ON THE AFFECTED SITE WHICH REVEALED A BROKEN PLATE. THE PLATE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. A NEW LOCKING COMPRESSION PLATE WAS IMPLANTED IN THE FEMUR ON (B)(6) 2018. PATIENT STATUS AND SURGICAL OUTCOME ARE BOTH UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 48MM. THIS IS REPORT 1 OF 2 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4) WHICH CONTAINS 10 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819720 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 48MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L132681 07611819125117

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention