BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SKYHOOK RETRACTOR SYSTEM

    MDR report key: 736566 · Received July 5, 2006

    Report

    Report Number
    1519227-2006-00001
    Event Type
    Malfunction
    Date Received
    July 5, 2006
    Date of Event
    June 8, 2006
    Report Date
    June 20, 2006
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REINSERTING OF CUT CABLE, WHICH IFU WARNS IS DANGEROUS TO DO. THERE IS ALSO EVIDENCE THAT THE CABLE WAS WOUND COMPLETELY ONTO SPOOL, WHICH CAN CAUSE KINKING OF CABLE PER IFU CAUTIONS AND WHICH CAN CAUSE THE CABLE TO FRAY. SEE ATTACHMENT 4 FOR PEMCO'S EVAL OF RETRACTOR. REC'D RATCHET/RAKE WITH PIVOT HUB AND ALUMINUM GEARBOX. THE CABLE WAS NOT CONNECTED TO THE PIVOT HUB AND NO REMAINS OF CABLE WERE IN PIVOT HUB. THE SET SCREW WAS INTACT. THE PIVOT HUB AND SPOOL CAP HAVE RUB MARKS ON THEM WHICH OCCUR ONLY WHEN THE CABLE IS COMPLETELY AND TIGHTLY WOUND UP WHICH CAUSES STRESS ON THE CABLE WHERE CONNECTED TO THE PIVOT HUB. THE CABLE APPEARS TO BE A RULTRACT CABLE. IT WAS FOUND TO BE 1/4" SHORTED THAN ORIGINALLY SUPPLIED AND BRAZED TIP WAS MISSING. THE TIP SHOULD HAVE BEEN IN THE PIVOT HUB AND HELD IN PLACE WITH THE CABLE SET SCREW. THE END OF THE CABLE HAD BEEN GROUND AS EVIDENCED ON THE SMOOTH END OF THE CENTER WINDING. THE OUTER WINDINGS OF THE CABLE HAVE SHINY OR RUB MARKS WHICH INDICATE THE CABLE WAS REINSERTED INTO THE PIVOT HUB AND THE SET SCREW WAS PARTIALLY TIGHTENED AS INDICATED BY A LONG DEEPER RUB MARK. THE BRAZED TIP OF A NEW RULTRACT CABLE ALLOWS FOR PROPER LOCKING OF THE CABLE IN THE PIVOT HUB. NOT HAVING A BRAZED TIP AND REINSERTING THE CABLE DID NOT ALLOW FOR A SECURE LOCKING OF THE CABLE. IN CONCLUSION, THE RATCHET/RAKE WAS NOT USED ACCORDING TO INSTRUCTIONS (COMPLETELY WINDING CABLE ONTO SPOOL) WHICH CAUSED THE CABLE TO FRAY. THE CABLE WAS ALTERED AND WAS REINSERTED INTO THE PIVOT HUB.

    Description of Event or Problem · 1

    THE CABLE FROM A RULTRACT SKYHOOK RETRACTOR "SNAPPED" DURING CABG SURGERY, "WHEN DR WENT TO TIGHTEN CABLE - IT JUST SNAPPED." HOSPITAL REPORTED NO DEATH OR SERIOUS INJURY, HOSP REPORTED ON MDR FILED. IMPACT ON PT WAS "NONE." FEW MINUTE DELAY WHILE ANOTHER RETRACTOR WAS SET-UP. SEE ATTACHMENTS 1, 2, & 3 FOR HOSP ACCOUNTS OF EVENT. PEMCO CONCLUDED AFTER ITS EVAL OF THE CABLE THAT IT DID NOT BRAKE, IT FELL/SNAPPED OUT OF THE HUB, DUE TO BEING MODIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RULTRACT SKYHOOK RETRACTOR SYSTEM SURGICAL RETRACTOR GAD PEMCO, INC. 4100-IMR-6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN