BEUDAMED
    FDA Adverse Event Other Summary report: N

    THREADED GUIDE PIN 3.2MM X 375MM

    MDR report key: 4847971 · Received June 11, 2015

    Report

    Report Number
    9613350-2015-00658
    Event Type
    Other
    Date Received
    June 11, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICE OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHARGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE INNER TYVEK LID WAS ATTACHED TO THE OUTER BLISTER, IT WAS NOT POSSIBLE TO OPEN THIS TYVEK LID APPROPRIATELY. THE DEVICE WAS NOT IMPLANTED. THEREFORE NO SURGICAL REPORT WAS AVAILABLE. THE MANUFACTURE RECEIVED THE DEVICE FOR INVESTIGATION, THE INNER TYVEK LID EDGE WAS SEALED TO THE OUTER BLISTER. THE PRODUCT COULD NOT BE OPENED AS INTENDED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE PACKAGING EMPLOYEE PACKAGED THE DEVICE INTO THE OUTER BLISTER, BUT HE DID NOT FOLD OVER THE EDGE OF THE INNER TYVEK LID. AFTER SEALING THE OUTER TYVEK LID TO THE OUTER BLISTER, THE EDGE OF THE INNER BLISTER GOT STICKED TO THE OUTER TYVEK SHEET. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS POINT OF TIME AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY A THREADED GUIDE PIN 3.2MM X 375MM WAS OPEN AND IT WAS FOUND THAT THE INNER LID WAS SEALED WITH THE OUTER LID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381056 THREADED GUIDE PIN 3.2MM X 375MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMED HSB ZIMMER GMBH NA 15113423

    Patients

    Seq Age Sex Outcome Treatment
    1 Other