BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN

    MDR report key: 7060189 · Received November 27, 2017

    Report

    Report Number
    1923569-2017-00155
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 21, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. NO DEVICE RETURNED

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE MANUFACTURER DATE: SEPTEMBER 2005. ONE (1) NL3785-009 VM RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN. WAS REPORTED AS THE COMPLAINT. THE LOT CODE WAS REPORTED AS I05 (SEPT 2005), AGE OF THE SAMPLE WAS POSSIBLY OVER 12 YEARS OLD. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TIP OF THE SAMPLE BROKE OFF WHILE IN USE. THE PATIENT HAD NO INJURY AND BROKEN OFF PIECE WAS NOT FOUND IN THE PATIENT UPON PERFORMING X-RAY OF THE SURGERY AREA. THE PATIENT¿S MEDICAL STATUS WAS STABLE AFTER THE EVENT AND IT WAS UNKNOWN BY CUSTOMER IF ANY PART OF THE SAMPLE BROKE OR FELL INTO THE PATIENT. THE BROKEN PIECE WAS NOT RECOVERED AND NOT RETURNED FOR EVALUATIONS. UPON REQUESTS, THE CUSTOMER WAS NOT ABLE TO SEND PHOTOS OF THE SAMPLE NOR THE REST OF THE SAMPLE IN FOR EVALUATIONS AND INVESTIGATIONS. BASED ON THE CUSTOMER DESCRIPTION, THE SAMPLE¿S TAPERED SEMI-SHARP HOOK TIP THAT BENDS OUT AT A 90 DEGREE ANGLE WAS MOST LIKELY THE AFFECTED PART THAT BROKE OFF. THE TIP IS MANUFACTURED TO BE 0.079 +/-0.005 INCHES IN TIP LENGTH. THE NECK WIDTH AT THE TIP IS MANUFACTURED TO BE AT 0.021 IN +/-0.005 IN. THE NL3785-009 ORIGINATES FROM A SINGLE PIECE OF A 420 SERIES STAINLESS STEEL ROD THAT IS MACHINED TO SHAPE, FOLLOWED BY FINAL FINISHING STEPS NECESSARY TO REFINE AND MEET FINAL PRINT SPECIFICATIONS. UPON BENDING OF THE TIP AND ADJUSTMENTS, THE PRODUCT IS HEAT-TREATED TO HARDEN THE METAL TO CONFORMING HARDNESS. IT IS UNKNOWN EXACTLY WHERE ALONG THE TIP THE SAMPLE BROKE OFF. THE ROOT CAUSE CANNOT BE CONCLUDED WITHOUT SAMPLE REVIEW. DEVICE HISTORY RECORDS FOR NL3785-009 FROM LOT CODE I05 WERE REVIEWED: ALL WORK INSTRUCTIONS WERE COMPLETED ACCORDINGLY. QA INSPECTIONS WERE PERFORMED. NO ISSUES RELATED TO THE FAILURE MODE WERE IDENTIFIED. CONCLUSION(S): NO SAMPLES AND/OR SAMPLE PHOTOS WERE RETURNED FOR EVALUATIONS AND VERIFICATIONS. NO LOT CODE WAS REPORTED FOR DHR REVIEW. ROOT CAUSE COULD NOT BE VERIFIED AND CONCLUDED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL SUBMISSION THE DATE WAS INCORRECTLY PROVIDED AND SHOULD HAVE BEEN (B)(6) 2017.

    Description of Event or Problem · 1

    RECEIVED A MEDWATCH REPORT FROM THE CUSTOMER REPORTING, THE TIP OF A CAREFUSION (B)(4) NERVE HOOK BROKE OFF WHILE IN USE. PATIENT IS A (B)(6) YEAR OLD MALE, PATIENT ID (B)(6). ADDITIONAL INFORMATION RECEIVED 15NOV2017: THE CUSTOMER REPORTED THE MEDWATCH WAS FILED WITH THE FDA, NO REPORT NUMBER WAS PROVIDED. " WE ONLY HAVE THE PATIENT IDENTIFIER, WHICH IS THE SAME NUMBER FOR YOUR MEDWATCH REPORT." PATIENT HAD NO INJURY. PATIENT DID UNDERGO AN X-RAY TO DETECT A FOREIGN BODY, WHICH WAS NEGATIVE. PATIENT'S MEDICAL STATUS AFTER THE EVENT WAS STABLE. UNKNOWN IF ANY PART OF THE DEVICE BROKE OR FELL INTO PATIENT'S BODY FIELD. PATIENT DID HAVE AN X-RAY IN THE OR BY FLUORO ON (B)(6) 2017 OF THE CERVICAL SPINE WHICH WAS NEGATIVE FOR FB. UNKNOWN HOW THE EVENT WAS RESOLVED. THE PROCEDURE WAS AN ANTERIOR CERVICAL DISKECTOMY WITH ARTHRODESIS, C4-5, C5-6, ULNAR NERVE RELEASE, WHICH WAS COMPLETED AS PLANNED. THE DEVICE IS NOT AVAILABLE FOR RETURN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838948 RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN INSTRUMENT, MICROSURGICAL GZX CAREFUSION, INC I05

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention