BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BATTERY POWERED HANDPIECES

    MDR report key: 14601173 · Received June 6, 2022

    Report

    Report Number
    8030965-2022-03333
    Event Type
    Injury
    Date Received
    June 6, 2022
    Report Date
    May 20, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. CATALOG NUMBER, SERIAL NUMBER AND LOT NUMBER ARE UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER WAS UNKNOWN; THEREFORE, UDI: UNKNOWN. 510(K) NUMBER IS UNKNOWN. THE MANUFACTURING SITE NAME AND ADDRESS ARE UNKNOWN. DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Description of Event or Problem · 0

    THE LITERATURE ARTICLE ENTITLED, "PULSED ELECTROMAGNETIC FIELD THERAPY IMPROVES OSSEOUS CONSOLIDATION AFTER HIGH TIBIAL OSTEOTOMY IN ELDERLY PATIENTS¿A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL" WRITTEN BY PATRICK ZIEGLER, ANDREAS K. NUSSLER, BENJAMIN WILBRAND, KARSTEN FALLDORF, FABIAN SPRINGER, ANNE-KRISTIN FENTZ, GEORG ESCHENBURG, ANDREAS ZIEGLER, ULRICH STOCKLE, ELKE MAURER, ATESCH ATESCHRANG, STEFFEN SCHROTER AND SABRINA EHNERT. THE ARTICLE'S PURPOSE WAS TO STUDY HOW EXTREMELY LOW-FREQUENCY PULSED ELECTROMAGNETIC FIELD (ELF-PEMF) THERAPY IS PROPOSED TO SUPPORT BONE HEALING AFTER INJURIES AND SURGICAL PROCEDURES, BEING OF SPECIAL INTEREST FOR ELDERLY PATIENTS. THE STUDY AIMED AT INVESTIGATING THE EFFECT OF SPECIFIC ELF-PEMF, RECENTLY IDENTIFIED TO SUPPORT OSTEOBLAST FUNCTION IN VITRO, ON BONE HEALING AFTER HIGH TIBIAL OSTEOTOMY (HTO). THE ARTICLE REPORTED THAT TWO UNKNOWN PATIENTS (ONE FROM EACH GROUP) W/AN UNKNOWN DEPUY SYNTHES BATTERY POWERED HANDPIECE DEVICE, EXPERIENCED POST OPERATIVE INFECTIONS REQUIRING ADDITIONAL INTERVENTION. DEPUY PRODUCT INVOLVED: UNKNOWN BATTERY POWER HANDPIECE (TRS) DEVICE. ADVERSE EVENT: POST OPERATIVE INFECTION REQUIRING ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160542 UNKNOWN BATTERY POWERED HANDPIECES MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention