BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3883905 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11973
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN ADDITIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. (B)(4). THE DEVICE IS DETERMINED SUITABLE FOR ITS INTENDED AND RECOMMENDED USE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT/EXPLANT DATE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE PART WAS CHIPPED. THE REPAIR TECHNICIAN REPORTED THE PART WAS DAMAGED. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED FOR FURTHER EVALUATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED A DEVICE THAT WAS DAMAGED DUE TO AN EVENT THAT OCCURED DURING SURGERY. THE A HELICAL BLADE INSERTER WOULD NOT RELEASE FROM THE HELICAL BLADE THAT WAS ONLY PARTIALLY INSERTED. AFTER THE HELICAL CONNECTING SCREW WAS REMOVED, THE SURGEON HAD TO REMOVE THE HELICAL BLADE WITH AN EXTRACTION INSTRUMENT. THE INSERTER, PART (B)(4), WAS DAMAGED AS THE SURGEON TRIED TO BACK IT OFF THE BLADE BY HITTING THE INSERTER WITH A MALLET, RESULTING IN DAMAGE TO THE HANDLE OF THE HELICAL BLADE INSERTER. THE HELICAL BLADE WAS REPOSITIONED AND INSERTED COMPLETELY. THE HELICAL BLADE WAS RE-POSITIONED AND WAS SUCCESSFULLY INSERTED COMPLETELY AND REMAINS IN THE PATIENT. THE PROCEDURE WAS DELAYED BY 45 MINUTES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361347 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5098377

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention