BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8615749 · Received May 16, 2019

    Report

    Report Number
    8030965-2019-64021
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 16, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT DEVICES ATTACHED. ACCORDING TO THE RECEIVED X-RAYS THE COMPLAINT CONDITION THAT AN UNKNOWN SCREW IS BROKEN CAN BE CONFIRMED. 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

    EXACT DATE IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. PMA/510(K) NUMBER IS NOT AVAILABLE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2019, THE HOSPITAL CONFIRMED THAT THE SECOND UNKNOWN SCREW ON THE ULNA SIDE WAS BROKEN. ORIGINALLY, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR THE DISTAL RADIUS FRACTURE WITH VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE AND UNKNOWN SCREWS ON (B)(6) 2019. DURING THAT SURGERY, THE SURGEON FOUND OUT THE SHORTENING OF THE ULNA. NO PREOPERATIVE X-RAYS WERE TAKEN. HOWEVER, ON (B)(6) 2019, THE HOSPITAL FOUND OUT VIA X-RAYS THAT THE ULNA WAS DEFORMED. THE SURGEON THOUGHT THAT TWO SCREWS ON ULNA SIDE WERE BROKEN, ALTHOUGH IT COULD NOT BE CONFIRMED ONLY BY IMAGES OF X-RAYS. THE SURGEON THEN COMMENTED THAT THE BREAKAGE WAS CAUSED BY AN INSTABILITY OF THE RADIUS ON ULNA SIDE, WHICH WAS DUE TO THE COMMINUTED FRACTURE AND THE ULNA SHORTENING. NO RE-OPERATION WAS PLANNED BECAUSE THE SURGEON THOUGHT THAT THE DEFORMATION OF ULNA DOES NOT SEEM TO BE WORSENING AND THE BONE UNION IS PROGRESSING. CONCOMITANT DEVICES: VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART# 04.111.531S, LOT# L884852, QUANTITY 1); SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410192 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention UNK - SCREWS: TRAUMA| VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA