BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT

    MDR report key: 6843939 · Received September 5, 2017

    Report

    Report Number
    1719045-2017-10881
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    August 15, 2017
    Report Date
    August 15, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K120854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE ( 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT, PART NUMBER 02.118.402, LOT NUMBER H080909). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED FOR THE RETURNED DEVICES AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 02.118.402 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT . THE RETURNED PLATE WAS VISUALLY EXAMINED AND THE THREADS OF EACH VA HOLE WERE FOUND TO BE DEFORMED. VARIABLE ANGLE (VA) PLATE HOLES SHOW WEAR CONSISTENT WITH ATTEMPTED SCREW INSERTION. A DIMENSIONAL INSPECTION OF FEATURES RELATED TO THIS COMPLAINT COULD NOT BE PERFORMED AS THE VA PLATE HOLES THREAD HAS BEEN DEFORMED DUE TO ATTEMPTED SCREW INSERTION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. IT IS UNKNOWN IF A REQUIRED DRILL GUIDE OR TORQUE LIMITER WAS USED AS REQUIRED TO LOCK THE SCREWS TO THE PLATE. 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 PATIENT¿S IDENTIFIER IS REPORTED AS (B)(4). ADDITIONAL DEVICE PRODUCT CODE: HWC LOT NUMBER, UDI NUMBER. DEVICE RETURNED TO MANUFACTURER A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 02.118.402, LOT # H080909: DATE OF MANUFACTURE: 13 APRIL 2016, MANUFACTURING SITE: (B)(4), EXPIRATION DATE: N/A (NON-STERILE): THE DEVICE HISTORY RECORD (DHR) FOR LOT H080909, WORK ORDER 4445969, PART NUMBER 02.118.402 (DESCRIPTION: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/ 4 HOLES/ RIGHT) WAS REVIEWED AND REVEALED NO MANUFACTURING ANAMOLIES AT THE TIME OF RELEASE. THE DHR REVIEW FOR LOT H080909 DOES NOT INDICATE ANY INFLUENCE IN RELATION TO THE COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. CORRECTED DATA: MANUFACTURER, OCCUPATION. 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 USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT DOB AND WEIGHT NOT PROVIDED FOR REPORTING. (B)(4) LOT NUMBER UNKNOWN. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4) USED FOR: DURING THE PROCEDURE, THREE (3) 12 MM 2.7 VARIABLE ANGLE (VA) SCREW WOULD NOT LOCK INTO A 2.7 VA LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, THE SURGEON ATTEMPTED TO SCREW A SHORT PLATE IN, THE 3 SCREWS WOULD NOT LOCK ON THE PLATE. HE REMOVED THE SHORTER PLATE AND THE 3 SCREWS AND NONE OF THEM WOULD SUCCESSFULLY LOCK. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT ANKLE ON (B)(6) 2017. DURING THE PROCEDURE, THREE (3) 12 MM 2.7 VARIABLE ANGLE (VA) SCREW WOULD NOT LOCK INTO A 2.7 VA LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE. AS THE SURGEON ATTEMPTED TO SCREW A SHORT PLATE IN, THE 3 SCREWS WOULD NOT LOCK ON THE PLATE. HE REMOVED THE SHORTER PLATE AND THE 3 SCREWS. HE WENT ON TO A LONGER PLATE AND WAS SUPPOSED TO USE A TOTAL OF 6 SCREWS. HOWEVER, THE SURGEON ROTATED THREE (3) SCREWS (THE SAME 3 SCREWS USED ON THE SHORTER PLATE) THROUGH FOUR (4) DIFFERENT HOLES, DISTALLY, AND NONE OF THEM WOULD SUCCESSFULLY LOCK. THE SURGEON WAS ABLE TO USE A NEW SCREW TO LOCK IN THE LONGER PLATE, DISTALLY. THIS DELAYED SURGERY FOR ABOUT 15 MINUTES. THE SURGEON WAS ABLE TO SCREW IN 4 HOLES OF THE LONGER PLATE, BUT DECIDED TO LEAVE TWO HOLES EMPTY DUE TO THE ISSUES. HE STATED THAT HE WOULD HAVE LIKED MORE SCREWS ON THE DISTAL END OF THE PLATE. THE PATIENT WAS IMPLANTED WITH ONE (1) LONGER PLATE (PART # 02.118.404, LOT # UNKNOWN) AND 4 NEW SCREWS. THE PATIENT STATUS WAS REPORTED AS SUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 5 PARTS. CONCOMITANT DEVICES REPORTED: 1 UNKNOWN SCREW. THIS REPORT IS 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622089 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT PLATE,FIXATION,BONE HRS SYNTHES ELMIRA H080909

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention