BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE Ø1 W/CRIMP L470 DOUBLE-LEAD TAN

    MDR report key: 3196086 · Received June 28, 2013

    Report

    Report Number
    2520274-2013-03959
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    K002110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT ONE OF THE CABLES THE SOLID PORTION OF THE CRIMPING PART IS DEFORMED. AT THE OTHER CABLE THE CRIMPING TUBE IS ONLY SLIGHTLY DEFORMED. BASED ON THESE FINDINGS THE CRIMPER WAS NOT ATTACHED IN THE CORRECT CRIMPING POSITION ONTO THE FIRST CABLE AND INSTEAD OF APPLYING THE PRESSURE ONTO THE TUBE THE PRESSURE WAS APPLIED ONTO THE SOLID PORTION BEHIND THE TUBE. THIS HAD TWO EFFECTS, FIRST THE CABLE WAS NOT CRIMPED AS REQUIRED AS THE PRESSURE WAS APPLIED ONTO THE SOLID PORTION AND SECOND THE JAWS OF THE CRIMPER DID GET DEFORMED AS VERY HIGH PRESSURE WAS APPLIED BECAUSE THE SOLID PORTION DID NOT EASE IN THE SAME MANNER AS THE TUBE. FINALLY THE SECOND CABLE WAS NOT CRIMPED CORRECTLY AS THE CRIMPER WAS DEFORMED AND DID THEREFORE NOT CLOSE AS REQUIRED ANYMORE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO RELATED ISSUES WERE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SCOLIOSIS CORRECTION SURGERY ON (B)(6) 2013 TO IMPLANT CABLES ALONG WITH USSII SCREWS AND 6MM TAN TURQUOISE RODS, THE SURGEON USED THE TORQUE LIMITING HANDLE TO CRIMP THE CABLES. IT WAS NOTED THAT AS HE WAS USING THE INSTRUMENT, IT WAS SNAPPING THE CABLES. AS A RESULT, THE SURGERY WAS PROLONGED APPROXIMATELY 1 HOUR TO INSERT 2 REPLACEMENT CABLES. THERE WAS NO ADVERSE EFFECT NOTED TO THE PATIENT. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295807 CABLE Ø1 W/CRIMP L470 DOUBLE-LEAD TAN JDQ SYNTHES USA P4627

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention