BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHORT CM LAG SCREW REAMER

    MDR report key: 3850991 · Received May 22, 2014

    Report

    Report Number
    9613350-2014-03542
    Event Type
    Other
    Date Received
    May 22, 2014
    Date of Event
    December 18, 2013
    Report Date
    May 5, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. IT IS STATED THAT THE PRODUCT WAS RETAINED BY THE HOSP. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING SURGERY, WHILE REAMING FOR THE PLACEMENT OF THE LAG SCREW, THE TIP OF THE LAG SCREW REAMER BROKE OFF INTO A FEW SMALL PIECES. THE PIECES WERE THEN RETRIEVED BY THE SURGEON UNDER X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306607 SHORT CM LAG SCREW REAMER ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDUL HSB ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other