BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø9

    MDR report key: 3072568 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01877
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION SHOWS THAT THE REAMER HEAD IS BROKEN. WE ASSUME THAT THIS BREAKAGE OCCURRED DUE TO WEAR AND TEAR OVER THE YEARS. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED AND NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 WITH A MALE PATIENT PRESENTED WITH A TIBIAL DIAPHYSIS FRACTURE, IT WAS REPORTED THE SYNREAM REAMER HEAD BROKE. REPORTEDLY, THE PATIENT HAD HARD BONES AND THE PATIENTS MEDULLARY CAVITY WAS NARROW. THE DOCTOR OPERATED ON THE PATIENT ACCORDING TO THE OPERATIVE PROCEDURE AND THE DOCTOR CHANGED THE REAMER HEAD FROM 8.5MM TO 9.0MM GRADUALLY AND KEPT REAMING. THE DOCTOR STOPPED THE REAMING AT THE FRACTURE LINE OF THE NARROWED AREA, AND THEN HE ADJUSTED HIS BODY FOR HOLDING REAMER PROPERLY. HE RESTARTED THE REAMING WITH POSITIVE ROTATION AND TRIED TO REMOVE THE REAMER. SUDDENLY, WITH THE SOUND OF BREAKING THE REAMER SHAFT WAS REMOVED. REPORTEDLY THE REAMER HEAD WAS BROKEN AND THE BROKEN PIECE REMAINED INSIDE OF MEDULLARY CAVITY. THE DOCTOR PERFORMED SKIN INCISION TO THE FRACTURED BONY PART AND REMOVED THE BROKEN PIECE. THE DOCTOR RESTARTED THE REAMING WITH CHANGING FROM 8.5MM REAMER HEAD TO 11.0MM REAMER HEAD. THE REAMING WAS COMPLETED SUCCESSFULLY AND THE OPERATION WAS FINISHED WITHOUT ANY FURTHER PROBLEM REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174856 SYNREAM REAMER HEAD Ø9 HTO SYNTHES GMBH 19891

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR