BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELBOW HINGE FIXATOR

    MDR report key: 7522111 · Received May 17, 2018

    Report

    Report Number
    8030965-2018-53818
    Event Type
    Injury
    Date Received
    May 17, 2018
    Report Date
    April 27, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819815070
    PMA / PMN Number
    K090658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NO.: 394.055. LOT NO.: 9893663. MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: 04.APR.2016. NO 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. NO NCRS WERE GENERATED DURING PRODUCTION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: INVESTIGATION SELECTION INVESTIGATION SITE: (B)(4). SELECTED FLOW: 2. DEVICE INTERACTION/FUNCTIONAL: VISUAL INSPECTION: THE COMPLAINT CONDITION IS NOT CONFIRMED. THE DEVICE IS NOT BROKEN AS COMPLAINED BUT IS SEPARATED. WE RECEIVED THE HINGED JOINT DISASSEMBLED IN THE TWO ARMS TOGETHER WITH THE CONNECTING SCREW AND NUT. WE COULD EASILY ASSEMBLE THE PARTS AS FORESEEN. IT IS ALSO VISIBLE THAT THE CONNECTING SCREW AND THE NUT WERE DISASSEMBLED BY THIRD PARTY APPLYING EXCESSIVE FORCE. VISIBLE SIGNS ON THE METAL PART INDICATES FORCIBLE DISMANTLING POST PRODUCTION. FUNCTIONAL TEST: AFTER SUCCESSFUL ASSEMBLING OF THE DEVICE, THE FUNCTION IS AS INTENDED. DOES THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION? NO, THE PART IS NOT BROKEN AS COMPLAINED BUT DISASSEMBLED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? THE PART CAN BE DISASSEMBLED AND ASSEMBLED AS FORESEEN. NO OTHER FAILURE MODE COULD BE IDENTIFIED. DIMENSIONAL INSPECTION: NO NECESSARY AS THERE IS NO MALFUNCTION OF THE DEVICE IN QUESTION. DOCUMENT/SPECIFICATION REVIEW: THE RISK ASSESSMENT FOR EXTERNAL FIXATOR DEVICES ADDRESSES THE HAZARD ¿ELBOW HINGE LOOSENS/COMES APART POSTOPERATIVELY¿. THIS COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. NO PRODUCT FAULT COULD BE IDENTIFIED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 PROCODE: LXT. DATE OF IMPLANTATION IS UNKNOWN. IT IS UNKNOWN IF/WHEN DEVICE WAS EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN ELBOW HINGE FIXATOR WAS APPLIED TO DISLOCATION FRACTURES ON THE RADIUS BONE HEAD ON AN UNKNOWN DATE. THIS SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FOUND THREE WEEKS AFTER SURGERY THAT THE HINGE ON THE FIXATOR HAD FALLEN APART BECAUSE THE PIN IN THE HINGE CAME OFF. THE HINGE WAS REASSEMBLED WITH SUTURES, AND THE FIXATOR CONTINUED TO BE USED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PATIENT STATUS IS STABLE. THIS COMPLAINT IS FOR AN ELBOW HINGE FIXATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363825 ELBOW HINGE FIXATOR APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9893663 07611819815070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention