BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAWBLADES

    MDR report key: 3229145 · Received July 16, 2013

    Report

    Report Number
    3002806535-2013-00129
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    October 18, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    DZH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED AND EVALUATED. THE EVALUATION CONFIRMED THAT THE SAW BLADES IN THE KIT COULD ONLY BE USED FOR A CEMENTED PROCEDURE. THE SAWBLADES ARE GENERIC AND ARE CURRENTLY BEING EXCHANGED TO THE CORRECT VERSIONS. THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. SEE ALSO: 3002806535-2013-00128.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PATIENT INJURY WAS REPORTED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. MANUFACTURE DATE - UNKNOWN. THIS IS 2 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR: 3002806535-2013-00128.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE ON (B)(6) 2013, AN OXFORD SHORT ROD INSTRUMENT AND THE CORRECT SAW BLADES WERE MISSING FROM THE LOANER KIT WHICH RESULTED IN A 30-45 MINUTE DELAY IN SURGERY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328289 SAWBLADES BLADE, SAW, GENERAL AND PLASTIC SURGERY DZH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R