BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 8317244 · Received February 7, 2019

    Report

    Report Number
    2939274-2019-56338
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 20, 2019
    Report Date
    January 20, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194114
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. SUPPLIER LOT NUMBER 2100191. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 352.040, LOT: 2100191. MANUFACTURING LOCATION: BETTLACH, RELEASE TO WAREHOUSE DATE: JUL 09, 2004. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL FUNCTIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PITUITARY INSTRUMENT WAS USED TO RECOVER THE REMAINS OF THE REAMER HEAD FRAGMENTS AND ADDITIONAL X-RAYS HAVE BEEN TAKEN TO VISUALIZE THE FRAGMENT THAT RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE USING A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FOR THE RIGHT HIP, THE MEDULLARY REAMER HEAD BECAME INCARCERATED IN THE ISTHMUS OF THE RIGHT FEMUR. THE SURGEON PULLED THE FLEXIBLE REAMER SHAFT OUT OF THE FEMUR, LEAVING THE BALL TIP REAMING ROD AND THE MEDULLARY REAMER HEAD IN THE SHAFT. THE SURGEON THEN PULLED THE BALL TIP REAMING ROD OUT OF THE FEMUR WITH HALF OF THE REAMER HEAD ATTACHED TO THE REAMING ROD AND THE OTHER HALF LEFT WITHIN THE INTERTROCHANTERIC REGION OF THE FEMUR. THE SURGEON USED SEVERAL INSTRUMENTS TO RECOVER THE REMAINING REAMER HEAD FRAGMENTS BUT WAS UNABLE TO RETRIEVE ALL OF THE FRAGMENTS. THE REMAINING REAMER HEAD FRAGMENT WAS LEFT AT THE LESSER TROCHANTERIC REGION. THE FRAGMENT WAS LEFT IN A LOCATION THAT DID NOT INTERFERE WITH THE IMPLANTATION OF THE CEPHALOMEDULLARY DEVICE. AFTER THE BROKEN REAMER HEAD INCIDENT WAS RESOLVED, A SECOND FLEXIBLE REAMER SET WAS OPENED TO OBTAIN AN ADDITIONAL REAMER HEAD AND EXTRA FLEXIBLE REAMER SHAFTS, SO THAT THE SURGEON COULD PROCEED WITH REAMING THE CANAL FOR THE NAIL. IT WAS DISCOVERED THAT TWO (2) FLEXIBLE REAMER SHAFTS IN THE SECOND SET WERE WORN. THESE FLEXIBLE REAMER SHAFTS DID NOT SECURELY CAPTURE THE FLEXIBLE REAMER HEADS AND THEREFORE WERE NOT USED DURING THE SURGERY. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS IN UNKNOWN. CONCOMITANT PRODUCT REPORTED: REAMING ROD WITH BALL TIP (PART#: 351.706S, LOT#: UNKNOWN, QUANTITY #: 1), UNKNOWN TFNA NAIL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY #: 1), REAMER HEADS (PART#: 352.130, LOT#: UNKNOWN, QUANTITY #: UNKNOWN). THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109129 5.0MM FLEXIBLE SHAFT REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4919633 10886982194114

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR