BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS: CFN

    MDR report key: 8951668 · Received August 30, 2019

    Report

    Report Number
    8030965-2019-67891
    Event Type
    Injury
    Date Received
    August 30, 2019
    Report Date
    August 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CFN NAIL / UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH AN INTRAMEDULLARY NAIL OF FEMUR CANNULATED FEMORAL NAIL (CFN) WITH A PROXIMAL AND DISTAL LOCKING BOLT 10 YEARS AGO. POSTOPERATIVELY PATIENT PRESENTED SHORTENING OF THE LIMB DUE TO IMPLANTED IMPLANT. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO PERFORM REMOVAL OF THE DISTAL BOLT, TO PERFORM OSTEOTOMY IN DIFIISIS AND TO PULL TO GET THE DISTAL THIRD OF THE FEMUR TO SLIDE OVER THE NAIL AND TO PERFORM DISTAL BLOCK WITH A 5.0 MM LOCKING SCREW, AND THUS ACHIEVE LIMB LENGTHENING. IT WAS REPORTED THAT THE LOCKING SCREW DID NOT CORRESPOND TO THE SPECIFICATIONS OF THE IMPLANTED MATERIAL, BUT STILL THE SPECIALIST DECIDED TO CONTINUE WITH THE PLANNING. DURING REVISION PROCEDURE, WHEN MAKING THE DISTAL HOLE BROCADE TO PLACE LOCKING SCREW IN THE INTRAMEDULLARY NAIL, THE 4.2 MM DRILL BIT BROKE LEAVING THE TIP INSIDE THE INTRAMEDULLARY CANAL OF THE FEMUR, MAKING ITS REMOVAL DIFFICULT. BROKEN TIP REMAINED IN THE PATIENT. AFTER THIS SURGEON DECIDED TO DRILL THE NEXT HOLE AND PLACES 5.0 MM LOCKING SCREW. THE CFN NAIL WAS NOT REMOVED, ONLY 4.9 MM LOCKING BOLT WAS REMOVED AND REPLACED WITH 5.0 MM LOCKING SCREW 56 MM. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY BY CHANGING THE DRILL BIT TO ANOTHER DRILL BIT. PATIENT OUTCOME IS UNKNOWN. THIS REPORT CAPTURES THE POSTOPERATIVE EVENT OF LIMB SHORTENING, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP ISSUE OF 4.2 MM DRILL BIT BREAKAGE THIS REPORT IS FOR ONE (1) UNKNOWN CFN NAIL. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745188 UNK - NAILS: CFN NAIL, FIXATION, BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention