BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIERTZ-SHOEMAKER RIB SHEARS 9-3/4IN

    MDR report key: 3071513 · Received April 22, 2013

    Report

    Report Number
    1423507-2013-00003
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 25, 2013
    Manufacturer
    CAREFUSION
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT INSTRUMENT WAS PROVIDED AND AN EVALUATION WAS PERFORMED. THIS INSTRUMENT WAS MANUFACTURED FOR CAREFUSION BY A 3RD PARTY SUPPLIER. THE INSTRUMENT DOES NOT HAVE A COMPLETE LOT CODE AND IS ONLY STAMPED WITH "K." BASED UPON THIS LOT CODE, IT WAS CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED IN 1983. HOWEVER, WITHOUT THE COMPLETE LOT CODE THE EXACT SUPPLIER COULD NOT BE DETERMINED THAT MANUFACTURED THE INSTRUMENT IN 1983. THE INSTRUMENT HAS BEEN MANUFACTURED BY OUR CURRENT SUPPLIER SINCE 2000. THERE WAS A DIFFERENT 3RD PARTY SUPPLIER THAT MANUFACTURED THE INSTRUMENT FROM 1986 UNTIL 2000. AN EVALUATION WAS PERFORMED BY AN IN-HOUSE INSTRUMENT SPECIALIST AT CAREFUSION SINCE THE SUPPLIER IS UNKNOWN. IT IS POSSIBLE THAT THE INSTRUMENT HAS BEEN IN USE FOR OVER 29 YEARS. THE AGE OF THE INSTRUMENT AND USAGE OVER TIME MOST LIKELY CONTRIBUTED TO THE END OF LIFE INSTRUMENT FAILURE. THERE WERE NO OBVIOUS MANUFACTURING OR MATERIAL DEFECTS IDENTIFIED WITH THE INSTRUMENT. THE LIMITATIONS ON REPROCESSING SECTION OF THE INSTRUCTIONS FOR USE (IFU) EXPLAINS THAT REPROCESSING HAS MINIMAL EFFECT ON THESE DEVICES. END OF LIFE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE COMPLETED AS THE COMPLETE LOT NUMBER AND SUPPLIER IS UNKNOWN. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED FOR THIS INSTRUMENT OVER THE LAST TWO YEARS. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS OF ANY KIND FOR THIS INSTRUMENT. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED AND EVALUATED.

    Description of Event or Problem · 1

    SCREW FELL OUT INFORMATION RECEIVED FROM MEDWATCH REPORT #3600030000-2013-0001.  PATIENT WAS HAVING PROCEDURE THAT REQUIRED NOTCHING OF TWO RIBS.  SURGERY WAS NON-EVENTFUL.  TWO DAYS LATER, PATIENT REQUIRED CHEST X-RAY--NOTED OBJECT THAT APPEARED IN AREA OF LUNG.  A DAY LATER, PATIENT REQUIRED A CHEST CT SCAN FOR PNEUMONIA.  PHYSICIAN ABLE TO IDENTIFY OBJECT AS SCREW.  OR CALLED WITH DIMENSIONS OF SCREW AND ASKED TO CHECK FOR LOST SCREW.  SCREW LOCATED IN SOFT TISSUE BEHIND RIBS, NOT IN CHEST CAVITY. ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER ON (B)(6) 2013.  THE PATIENT WAS HAVING HIS RIB NOTCHED TO ACCESS HIS ESOPHAGUS.  NO HEALTHCARE PROFESSIONAL WAS INJURED.  THUS FAR, THERE HAS BEEN NO SURGICAL INTERVENTION.  BECAUSE THE SCREW LANDED IN THE SOFT TISSUE, AND WAS NOT DISCOVERED UNTIL A FEW DAYS POST OP, THE FAMILY WAS GIVEN THE OPTION OF WHETHER THEY WANT THE SCREW REMOVED.  THEY HAVE NOT OPTED TO HAVE THE SURGERY TO REMOVE THE SCREW, TO DATE.  THERE WAS NO DELAY IN THE PROCEDURE, AND WAS COMPLETED.  THE RIB SHEAR WORKED, AS IT SHOULD HAVE DURING THE PROCEDURE, SO THE SCREW POPPING OUT WAS NOT NOTED.  THE SHEAR WAS INSPECTED IN OR PROCESSING, TO MAKE SURE THAT IT CLIPPED PROPERLY, WHICH IT DID, EVEN DURING THE PROCEDURE.  ONCE THE SCREW WAS PHYSICALLY GONE, THE SHEAR COULD BE SQUEEZED OFF TRACK.  WAITING TO HEAR FROM THE OR ABOUT THE REPAIR HISTORY AND AGE OF THE DEVICE.  THE PATIENT WAS A (B)(6) MALE. ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER ON (B)(6) 2013.  THE SHEARS HAVE NEVER BEEN SENT OUT FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172780 GIERTZ-SHOEMAKER RIB SHEARS 9-3/4IN INSTRUMENTS, SURGICAL, CARDIOVASCULAR DWS CAREFUSION CH330 K

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other