BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR WIRE Ø1.6 L150/25

    MDR report key: 3192985 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03627
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    February 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE BROKE AT THE POINT TO THE BALL, COMPRESSION WIRE WAS USED IN STANDARD FASHION AS PER SURGICAL TECHNIQUE GUIDE TO COMPRESS FUSION SITE. THE LOCKING SCREWS HAD BEEN INSERTED EITHER SIDE OF THE FUSION SITE. LOCKING SCREWS HAD BEEN INSERTED EITHER SIDE OF THE FUSION SITE TO MAINTAIN COMPRESSION ACHIEVED BY WIRES AND FORCEPS. ON REMOVAL OF 25MM COMPRESSION WIRE FROM SITE PROXIMAL TO JOINT BEING FUSED WITH STANDARD WIRE DRIVER THE WIRE BROKE AT THE POINT WHERE IT ATTACHES TO THE BALL-ON THE NON-THREADED SIDE OF THE WIRE. EVENTUALLY THIS WIRE WAS REMOVED BUT CAUSED DELAYS TO THE SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292552 COMPR WIRE Ø1.6 L150/25 HWN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention