BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE PASSER, 'WORM'

    MDR report key: 3003311 · Received March 14, 2013

    Report

    Report Number
    1220246-2013-00033
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    March 2, 2010
    Report Date
    February 12, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MOST LIKELY CAUSE OF THE EVENT IS AS STATED IN THE EVENT: "THE WORM SUTURE PASSING DEVICE WAS RECEIVED BROKEN AND THE WIRE LOOP WAS BROKEN PRIOR TO THE CASE. THE SURGEON THEN ATTACHED STERI-STRIPS TO THE WIRE OF THE WORM TO ALLOW THE PASSING OF THE SUTURE THROUGH THE TIBIAL WALL." THE DEVICE IS A REUSABLE DEVICE. THE DIRECTIONS FOR USE FOR THE DEVICE STATES: " INSPECT THE INSTRUMENTS FOR DAMAGE PRIOR TO USE. IF DAMAGE IS DETECTED, DO NOT USE THE DEVICE PRIOR TO CONSULTING THE MANUFACTURER FOR GUIDANCE." THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE PCL PROCEDURE DONE. THE "WORM" SUTURE PASSING DEVICE WAS RECEIVED BROKEN AND THE WIRE LOOP WAS BROKEN PRIOR TO THE CASE. THE SURGEON THEN ATTACHED STERI-STRIPS TO THE WIRE OF THE WORM TO ALLOW THE PASSING OF THE SUTURE THROUGH THE TIBIAL WALL. (IT WAS NOTED THAT EXCELLENT PCL STABILITY WAS RESTORED WITH FULL RANGE OF MOTION). DUE TO THE SUBSTANTIAL DELAY AND INCREASED TOURNIQUET TIME DURING THE PROCEDURE, THE PATIENT CLAIMS TO HAVE SUFFERED SEVERE NERVE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107278 SUTURE PASSER, 'WORM' ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other