BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER

    MDR report key: 5988836 · Received September 29, 2016

    Report

    Report Number
    3004086872-2016-00004
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 29, 2016
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE PRODUCT RECEIVED: PRODUCT WAS UNAVAILABLE FOR RETURN. DEVICE IDENTIFICATION: 3910-900-091. VISUAL INSPECTION: WHERE PRODUCT WAS UNAVAILABLE FOR RETURN VISUAL INSPECTION WAS NOT PERFORMED. FUNCTIONAL INSPECTION: WHERE PRODUCT WAS UNAVAILABLE FOR RETURN VISUAL INSPECTION WAS NOT PERFORMED. ADDITIONAL INVESTIGATION NOTES: DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURE LOT REPORTED IN THE COMPLAINT INVESTIGATION. FURTHER REVIEW SHOWED NEEDLES, 3910-900-091, MANUFACTURED UNDER LOT 968662 MET THE PRINT REQUIREMENT OF 95% CONFIDENCE THAT 99% OF THE LOT WOULD MEET A MINIMUM OF 24 CYCLES WITH 95% CONFIDENCE THAT 99.2% WOULD MEET THE 24 CYCLE MINIMUM. INFORMATION REPORTED IN THE ALLEGED PROBLEM STATED THE NEEDLE WAS PASSED THROUGH A FETAL BOVINE DERMAL PATCH. A FETAL BOVINE DERMAL PATCH SIMULATES HUMAN TISSUE, BUT THE COMBINATION OF BOTH THE PATCH AND HUMAN TISSUE RESULTING IN MORE TISSUE GRASPED BY THE SUTURE PASSER MAY HAVE BEEN A FACTOR IN CAUSING THE NEEDLE TIP TO BREAK. WHERE THE PRODUCT WAS UNAVAILABLE FOR RETURN THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION RECEIVED BY E-MAIL STATED "A POST OPERATIVE X-RAY WAS TAKEN. IT SHOWED NO RETENTION OF THE TIP. IT COULD HAVE BEEN LOCATED IN CLOSE PROXIMITY TO ONE OF THE FOUR REELX IMPLANTED SO WE CAN NOT BE 100% SURE". ALLEGED PROBLEM CONFIRMED: WHERE THE PRODUCT WAS NOT RETURNED THE ALLEGED PROBLEM COULD NOT BE CONFIRMED. ACTUAL FAILURE MODE(S): NEEDLE BROKE ROOT CAUSE(S): WHERE THE PRODUCT WAS NOT RETURNED AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. MANUFACTURER ERROR: DEVICE HISTORY RECORD REVIEW SHOWED NO MANUFACTURE ERROR WITH THE MANUFACTURE LOT LISTED IN THE COMPLAINT INVESTIGATION. CAPA OPENED FOR ACTUAL FAILURE MODE: WHERE THE ROOT CAUSE COULD NOT BE DETERMINED A CORRECTIVE ACTION WAS NOT TAKEN. TRENDS FOR THIS REPORTED NON-CONFORMANCE WILL BE MONITORED. DEVICE WAS UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ALLEGED PROBLEM(S): THE STRYKER SALES REPRESENTATIVE REPORTED THAT THE SURGEON, MR (B)(6) WAS UNDERTAKING A ROTATOR CUFF REPAIR WITH PATCH AUGMENTATION AND WAS USING A SUTURE PASSER NEEDLE THAT TO GO THROUGH THE ROTATOR CUFF. THE TIP OF THE NEEDLE BROKE AND THE SURGEON SUSPECTS THIS OCCURRED WHILE HE WAS PASSING THE NEEDLE THROUGH THE FOETAL BOVINE DERMAL PATCH. THE CASE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT NEEDLE. AT THE TIME OF INTAKE, THE PATIENT WAS UNDERGOING AN X-RAY TO ASCERTAIN WHETHER THE TIP IS INSIDE THE JOINT. PRODUCT WILL NOT BE RETURNED. PRODUCT DISCARDED IN SHARPS BIN. X-RAYS HAVE BEEN REQUESTED. HOW WAS IT NOTICED: DURING SURGERY PROCEDURE COMPLETED SUCCESSFULLY: YES. MEDICAL INTERVENTION: YES. SURGICAL DELAY: NO. ADVERSE CONSEQUENCES DETAILS: X-RAY BEING UNDERTAKEN AT THE TIME OF REPORTING TO ASCERTAIN IF THE NEEDLE TIP IS IN THE PATIENT. EVENT OCCURRED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637679 SUTURE PASSER SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 968662

    Patients

    Seq Age Sex Outcome Treatment
    1