BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN APEX PIN

    MDR report key: 15102996 · Received July 26, 2022

    Report

    Report Number
    0008031020-2022-00363
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    May 8, 2017
    Report Date
    July 26, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF COMPLETE RADIAL NERVE PALSY AND PERSISTENT LOSS OF NERVE FUNCTION, WHICH REQUIRED REVISION, COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿ORTHOPAEDIC DEPARTMENT, SERVICIO CIRUGIA ORTOPEDICA, HOSPITAL SANTA CRUZ Y SAN PABLO, BARCELONA AUTONOMA UNIVERSITY, SPAIN ¿. THE TITLE OF THIS REPORT IS ¿RADIAL NERVE INJURY FOLLOWING ELBOW EXTERNAL FIXATOR: REPORT OF THREE CASES AND LITERATURE REVIEW ¿, PUBLISHED ON MAY 08, 2017, AND CAN BE FOUND AT DOI 10.1007/S00402-017-2711-1. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 3 PATIENTS. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT ONE (1) PATIENT EXPERIENCED COMPLETE RADIAL NERVE PALSY, PERSISTENT LOSS OF NERVE FUNCTION, THE RADIAL NERVE WAS EXPLORED SURGICALLY AND COMPLETE DISRUPTION OF THE NERVE WAS FOUND AT THE LEVEL OF DISTAL HUMERAL PIN. THIS REQUIRED BOTH ENDS OF THE NERVE TO BE DISSECTED AND MICROSURGICAL NEURORRHAPHY WAS PERFORMED. THE ARTICLE ADDITIONALLY STATES, ¿IN THREE OF THE PUBLISHED CASES, INCLUDING ONE OF OUR CASES, THE RADIAL NERVE WAS INJURED BY WINDING AROUND THE DRILL BIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723236 UNKNOWN APEX PIN PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention