BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN

    MDR report key: 8249396 · Received January 15, 2019

    Report

    Report Number
    2939274-2019-55860
    Event Type
    Injury
    Date Received
    January 15, 2019
    Report Date
    December 19, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10887587055251
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. D2: ADDITIONAL DEVICE PRODUCT CODE: HWC. H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 460.046, LOT: 9902271. MANUFACTURING LOCATION: ELMIRA, MANUFACTURING DATE: SEP 19, 2015. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NON-CONFORMANCES. THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: PRODUCT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION OBSERVED THAT THE TITANIUM LOCKING STRAIGHT PLATE (460.046, 9902271) WAS BROKEN INTO TWO FRAGMENTS, ONE WITH 4 HOLES AND THE LATTER WITH 9 HOLES. THE FRACTURE SURFACE APPEARS HOMOGENOUS WITH NO VOIDS, DARK SPOTS, OR OTHER IRREGULARITIES IN THE METAL. VERY MINOR SURFACE WEAR IN THE ANODIZATION OF THE TITANIUM WAS OBSERVED, CONSISTENT WITH THE AGE OF THE DEVICE (3+ YEARS). THE RECEIVED CONDITION OF THE DEVICE WAS DETERMINED TO AGREE WITH THE COMPLAINT DESCRIPTION. WHILE NO DEFINITIVE ROOT CAUSE OF THE ISSUE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. DURING THE DOCUMENT/SPECIFICATION REVIEW THE RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. ALL MEASUREMENTS PERFORMED WITH CALIPERS CA802 MET SPECIFICATIONS. THE COMPLAINT CONDITION WAS CONFIRMED AS THE 13 HOLE TITANIUM STERNAL LOCKING STRAIGHT PLATE (460.046, 990227) WAS DETERMINED TO BE BROKEN THROUGH VISUAL INSPECTION. NO NEW PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED UPON THE INVESTIGATION FINDINGS, NO ADDITIONAL CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE OF TWO (2) TITANIUM STERNAL LOCKING STRAIGHT PLATES AND TWENTY-THREE (23) UNKNOWN SCREWS DUE TO NONUNION AND BROKEN PLATES. IT WAS NOTED THAT THE PLATES AND SCREWS CAME OUT OF THE PATIENT. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE (ORIF) WITH IMPLANTATION OF THE PLATES AND UNKNOWN SCREWS ON (B)(6) 2015, TO REPAIR AN EXTERNAL FRACTURE. IT IS UNKNOWN IF THERE WERE FRAGMENTS FROM THE BROKEN DEVICES. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT REPORTED DEVICES: UNKNOWN SCREWS (PART # UNKNOWN, LOT NUMBER#, QUANTITY: 23). THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42766 TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 460.046 9902271 10887587055251

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention