BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 6H HD/4H SHAFT/LT

    MDR report key: 6701643 · Received July 11, 2017

    Report

    Report Number
    1000562954-2017-10129
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    June 29, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH/AGE, GENDER AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. (B)(4) LOT# UNKNOWN. DATE OF INITIAL IMPLANT PROCEDURE IS UNKNOWN. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(6). (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.111.641, LOT# 7617329. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 03, 2011. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 MANUFACTURING EVALUATION WAS COMPLETED: THE PLATE IS BROKEN IN TWO PIECES. THE ETCHED DATA ARE CONSISTENT WITH THE COMPLAINT DOCUMENTATION. THE RETURNED PLATE WAS RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT. THE PLATE IS BROKEN AT THE LEVEL OF THE K-WIRE HOLES K1-K5. THE TWO HOLES CANNOT BE MEASURED DUE TO THE DAMAGE. THE HOLES K2, K3, K4 ARE CONFORMING TO SPECIFICATION. CONSIDERING THAT THE K-WIRE HOLES ARE MANUFACTURED WITH THE SAME TOOLS AND PARAMETERS, THE DAMAGED HOLES WERE MANUFACTURED IN ACCORDANCE WITH SPECIFICATION AS WELL. THE PLATE THICKNESS AND WITH ARE CONFORMING TO SPECIFICATION. NO EVIDENCE OF NON-CONFORMANCES MANUFACTURING RELATED. CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEM, THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE RETURNED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. THE RAW MATERIAL HAS BEEN VERIFIED THROUGH REVIEW OF CERTIFICATE DOCUMENTED IN THE DEVICE HISTORY RECORD REVIEW AND NO ANOMALY WAS FOUND. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. 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 THE VARIABLE ANGLE LOCKING COMPRESSION TWO-COLUMN DISTAL RADIUS PLATE (VA-LCP) BROKE POST-OPERATIVELY. DATE OF INITIAL IMPLANT PROCEDURE IS UNKNOWN. THE PATIENT WAS REVISED ON (B)(6) 2017. NO INFORMATION ABOUT PATIENT OUTCOME AND CONDITION REPORTED. CONCOMITANT REPORTED PART: SCREWS. THIS REPORT IS FOR ONE (1) VARIABLE ANGLE LOCKING COMPRESSION TWO-COLUMN DISTAL RADIUS PLATE (VA-LCP). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: CORTEX SCREW STARDRIVE (PART# 401.762, LOT# 994354, QUANTITY 1). SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 8).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482375 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 6H HD/4H SHAFT/LT PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 7617329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN QUANTITY OF UNKNOWN SCREWS