BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/5H SHAFT/LT-STER

    MDR report key: 4875539 · Received June 29, 2015

    Report

    Report Number
    2520274-2015-14695
    Event Type
    Injury
    Date Received
    June 29, 2015
    Report Date
    June 18, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK092556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 04.111.551S, 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/5H SHAFT/LT-STER, LOT NUMBER 9220526). THE SUBJECT DEVICE WAS RECEIVED BROKEN THROUGH THE MIDDLE. THE SUBJECT DEVICE WAS RE-INSPECTED FOR ALL THE FEATURES RELEVANT TO THE COMPLAINT CONDITION. ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET PRODUCT SPECIFICATIONS. DUE TO POST PRODUCTION WEAR AND DEFORMATION IN THE FRACTURE REGION, A DIMENSIONAL INSPECTION COULD NOT BE PERFORMED. THE SUBJECT DEVICE IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. THE SUBJECT DEVICE WAS FORWARDED TO THE SYNTHES COMPLAINT HANDLING UNIT FOR ADDITIONAL EVALUATION. 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. THE PATIENT¿S AGE IS BETWEEN 80 AND 89. DATE OF EVENT: UNKNOWN. (B)(4). IMPLANT DATE: EXACT DATE UNKNOWN, IMPLANTED (B)(6) 2015. EXPLANT DATE: EXACT DATE UNKNOWN, EXPLANTED (B)(6) 2015. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE MFG DATE: UNKNOWN. 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

    NO NON-CONFORMANCE REPORTS 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. 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

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE 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 EU REPORTS AN EVENT IN JAPAN AS FOLLOWS: VA-TCP WAS USED FOR A DISTAL RADIUS FRACTURE CASE IN FEBRUARY 2015. IT WAS REPORTED THAT THE PLATE IN QUESTION PRODUCED FISSURES WITHIN OBLIQUE HOLE RIGHT AFTER THE SURGERY AND THE FISSURES BECAME LARGER. IN MAY 2015, DURING A ROUTINE CHECKUP, THE BREAKAGE OF THE PLATE IN QUESTION WAS CONFIRMED AS WELL AS NONUNION THE PATIENT. THE RE-OPERATION FOLLOWED TO EXTRACT THE BROKEN PLATE AND TO FIX TREATED AREA WITH ALTERNATIVE PLATE IN MAY 2015. IT WAS FURTHER REPORTED THAT THE REPORTED SCREWS WERE INTACT. THE PATIENT IS CURRENTLY UNDER OBSERVATION AND IS TO TAKE PLANNED REHABILITATION USED WITH SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS). THIS COMPLAINT INVOLVES ONE (1) PLATE, FOUR (4) UNKNOWN LOCKING SCREWS, THREE (3) UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS, AND ONE (1) UNKNOWN CORTEX SCREW. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419985 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/5H SHAFT/LT-STER PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 9220526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention