BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/RIGHT

    MDR report key: 6361290 · Received February 27, 2017

    Report

    Report Number
    3003506883-2017-10025
    Event Type
    Injury
    Date Received
    February 27, 2017
    Report Date
    February 1, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    UDI-DI
    10886982054142
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT IS UNKNOWN. ADDITIONAL PRODUCT CODE: HWC IMPLANT DATE IS UNKNOWN. EXPLANT DATE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART #: 02.211.232, LOT#: 7852605 (NON-STERILE) - 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/RIGHT. QUANTITY (B)(4): MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 17-NOV-2014. INSPECTION SHEET MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT LOT 7045599 WAS REVIEWED. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. NO NON CONFORMANCE REPORTS (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. A PRODUCT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED. SURGEON REPORTED THAT THE "PLATE/SCREW FAILED". ONE PLATE WAS RECEIVED AT CUSTOMER QUALITY (CQ) IN 2 PIECES. THE BREAK IS TRANSVERSE AND LOCATED IN THE MIDDLE THIRD OF THE PLATE IN THE CENTER OF THE ELLIPTICAL HOLE USED FOR GUIDE WIRES. THE 6 RETURNED SCREWS SHOW WEAR ASSOCIATED WITH IMPLANTATION AND EXPLANTATION BUT ARE ALL INTACT. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED PLATE IS ALREADY BROKEN. NO NEW MALFUNCTIONS WERE IDENTIFIED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DIMENSIONAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. RELEVANT DRAWING WAS REVIEWED DURING THIS INVESTIGATION. UNABLE TO DETERMINE A ROOT CAUSE BASED ON THE COMPLAINT DETAILS. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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 THE PATIENT HAD AN ORIGINAL SURGERY PROCEDURE DONE FOR A METATARSOPHALANGEAL JOINT ON AN UNKNOWN DATE WHERE A VARIABLE ANGLED (VA) 2.4MM/2.7MM LOCKING COMPRESSION PLATE (LCP), RIGHT AND 6 UNKNOWN SCREWS WERE IMPLANTED. SURGEON REPORTED THAT THE PLATE/SCREW FAILED. PATIENT IS SCHEDULED TO HAVE FOLLOW UP SURGERY ON (B)(6) 2017. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142985 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/RIGHT PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 7852605 10886982054142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention