BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLEAIRHOSE L5M F/SYST SYNTHES

    MDR report key: 3123622 · Received May 22, 2013

    Report

    Report Number
    8030965-2013-02355
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE COMPLAINED HOSE WAS FORWARDED TO THE RESPONSIBLE PLANT FOR FURTHER INVESTIGATION. BASED ON THE FINDINGS ON-SITE THE HOSE FIXATION WAS CONDUCTED CORRECTLY DURING MANUFACTURING PROCESS. MOST PROBABLY THE DISMANTLING OF THE INNER HOSE OF THE CRIMP SLEEVE HAS BEEN GENERATED DUE TO EXCESSIVE EFFORT. (STRONG TENSION E.G.). WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND IT IS POSSIBLE THAT BASED ON THE STRONG VISIBLE ABRASIONS, A TOOL COULD LEAD TO THIS PROBLEM. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DHR REVIEW CONFIRMS THAT THE DEVICE WAS CONFORMING TO SPECIFICATIONS; NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PATIENT WITH A RIGHT FRACTURED CLAVICLE UNDERWENT SURGERY ON (B)(6) 2013. THE COMPACT AIR DRIVE MOTOR AND DOUBLE AIR HOSE WERE ASSEMBLED AND CONNECTED TO THE MANOMETER. THE MANOMETER WAS REVIEWED WITH THE COUPLING. UPON OPENING THE BULLET, THE HOSE WAS FORCIBLY DETACHED AND HIT THE OPERATOR. THIS LED TO A REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225579 DOUBLEAIRHOSE L5M F/SYST SYNTHES HWE SYNTHES GMBH SER. NO. 41224

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention