BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-L RETRACTOR LUMBAR BODY DBL HNG 200MM

    MDR report key: 6440139 · Received March 28, 2017

    Report

    Report Number
    1923569-2017-00042
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    December 22, 2016
    Report Date
    June 6, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GZT
    PMA / PMN Number
    K964402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) S-0102 S-L RETRACTOR LUMBAR BODY DBL HNG 200 MM WAS REPORTED AS THE COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATIONS, NO PICTURES OR FURTHER EVIDENCE WERE SENT FOR REVIEW AND NO LOT CODE WAS REPORTED FOR THE SAMPLE. THE S-0102 RETRACTOR PRODUCT HAS PARTICULARLY LONG ARMS FOR FLEXIBILITY OF USAGE. THE RETRACTOR IS INTENDED TO FUNCTION WITH THE MUSCLE BLADES: MUSCLE BLADES ARE ATTACHED SEPARATELY TO THE BALL SNAP ASSEMBLY AT THE END OF THE RETRACTOR ARMS. THESE BLADES COME IN DIRECT CONTACT WITH THE AREA OF SURGERY ON THE PATIENT. THE CUSTOMER REPORTED MISSING SCREW ON THE SAMPLE DURING A SURGICAL PROCEDURE. IT WAS INFERRED FROM THE CUSTOMER DESCRIPTION THAT CUSTOMER DID NOT KNOW WHEN THE SCREW WENT MISSING, THE SCREW COULD NOT BE FOUND UPON SEARCHING SURROUNDING AREAS AND OPERATION ROOM. THE SCREW WAS NOT FOUND IN THE PATIENT¿S BODY FOLLOWING AN X-RAY CHECK BY RADIOLOGIST. PATIENT INJURY WAS NOT NOTED. IT WAS NOT REPORTED EXACTLY WHICH SCREW ON THE SAMPLE WAS MISSING. THERE ARE 7 SCREWS INSTALLED BY MANUFACTURING ON THE S-0102 PRODUCTS: 2 SCREWS (TA-0133 AND TA-0134) ON EACH ARM¿S JOINT/HINGES FOR A TOTAL OF 4, 1 TA-0223 BALL-SNAP SCREW ON EACH BALL-SNAP BLADE HOLDER ASSEMBLY FOR A TOTAL OF 2, AND 1 TA-0003 SCREW THAT HOLDS THE RATCHETING LEVER AND SPRING ASSEMBLY. IT SHOULD BE NOTED THAT THE TA-0133, TA-0134 AND TA-0003 SCREWS ARE ALL PRESSED/PEENED IN PLACE AFTER SCREWING IN TO AVOID BACKING OUT OR LOOSENING. THE TA-0223 BALL-SNAP SCREWS ARE HELD IN PLACE WITH LOCTITE GLUE TO ALSO AVOID BACKING OUT AND LOOSENING. IT IS NOT KNOWN EXACTLY HOW THE SCREW LOOSENED AND BACKED OUT. IT IS ALSO NOT KNOWN HOW OR IF THE CUSTOMER INSPECTED OR TESTED THE SAMPLE PRODUCT PRIOR TO USE. MOST PROBABLE ROOT CAUSES COULD BE INSUFFICIENT PRE-INSPECTIONS, INTENTIONAL DISASSEMBLY, CLEANING RELATED WEAR, MANUFACTURING ERROR AND/OR OLD AGE. FURTHER ANALYSIS AND ROOT CAUSE CONFIRMATION CANNOT BE COMPLETED DUE TO NO SAMPLE RECEIVED FOR REVIEW. IT SHOULD BE NOTED THAT ALL SCREWS ON THE S-0102 AND SIMILAR PRODUCTS ARE NOT MEANT TO BE REMOVED OR DISASSEMBLED. THE SCREWS ARE PRESSED AND GLUED IN PLACE TO AVOID BACKING OUT AND LOOSENING. CONCLUSION(S): NO SAMPLE WAS RETURNED FOR EVALUATIONS AND ROOT CAUSE DETERMINATION. THE REPORTED MISSING COMPONENT FAILURE MODE AND POSSIBLE ROOT CAUSES CANNOT BE VERIFIED FOR FINAL CONCLUSION WITHOUT SAMPLE OR PHOTOS REVIEW. IT SHOULD BE NOTED THAT THE GENERAL IFU FOR NEURO-SPINE PRODUCTS STATES THAT ANY DISASSEMBLY OF PRODUCTS NEEDED FOR GENERAL MAINTENANCE AND CLEANING SHOULD NOT REQUIRE A MECHANICAL TOOL (I.E. SCREWDRIVER). THE TA-0223 SCREW IS SECURED INTO PLACE WITH LOCTITE 648 (ADHESIVE) AND NOT MEANT TO BE DISASSEMBLED BY END USER. FOR ANY FURTHER ISSUES AND MISSING SCREWS, IT IS RECOMMENDED TO REPLACE OR REPAIR THE PARTS OF S-0102 AND OTHER SIMILAR PRODUCTS, BY SENDING TO THE AUTHORIZED NATIONAL REPAIR CENTER: (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). ON 07MAR2017, WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION.

    Description of Event or Problem · 1

    RECORD OPENED IN REFERENCE TO (B)(4), THIS RECORD CAPTURES SECOND ITEM NUMBER IN MEDWATCH. MEDWATCH REPORT MW5067803 RECEIVED STATES: DURING PROCEDURE, DOCTOR NOTICED THAT SCREW FROM THE VERSATRAC RETRACTOR ARM WAS MISSING, INSTRUMENT STILL FUNCTIONED AS NEED: FLOOR WAS SEARCHED AND DOCTOR EXAMINED WOUND TO LOOK FOR SCREW, BUT NONE WAS DISCOVERED; UNSURE WHETHER SCREW WAS IN THE INSTRUMENT WHEN THE CASE WAS STARTED OR NOT. X-RAY WAS TAKEN AND RADIOLOGIST CALLED TO ROOM TO REPORT NOT SEEING SCREW ON THE FILM EITHER. ON 10MAR2017 ADDITIONAL INFORMATION: CAN YOU PLEASE PROVIDE YOUR TITLE? RISK ANALYST. IF NOTICED DURING PATIENT USE: WAS THERE ANY PATIENT INJURY OR INTERVENTION? NO. WHAT WAS THE PATIENT¿S MEDICAL STATUS AFTER THE EVENT? (STABLE?) YES. WERE THERE ANY RETAINED OBJECTS? NO. IF YES, HOW WAS THE OBJECT RETRIEVED? DID THE PATIENT REQUIRE AN ADDITIONAL MEDICAL PROCEDURE SUCH AS AN X-RAY? YES. WAS THE PROCEDURE COMPLETED AS PLANNED? YES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220858 S-L RETRACTOR LUMBAR BODY DBL HNG 200MM RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY GZT CAREFUSION, INC S-0102 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1