BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE

    MDR report key: 8156530 · Received December 12, 2018

    Report

    Report Number
    8030965-2018-58956
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649859
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PART 04.037.031S, LOT H221492: MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: NOVEMBER 01, 2016. EXPIRATION DATE: OCTOBER 31, 2026. THE DEVICE HISTORY RECORD (DHR) DOCUMENTS WERE REVIEWED. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPONENT PART DOCUMENTS WERE REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION (BROKEN NAIL) BASED ON THE RECEIVED PICTURES. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS AN UNKNOWN DATE IN 2018. DATE OF IMPLANTATION IS AN UNKNOWN DATE IN (B)(6) 2018. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DATE OF CONCOMITANT THERAPY IS THE SAME AS DATE OF IMPLANTATION, AN UNKNOWN DATE IN (B)(6) 2018. 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. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. (B)(4). 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) LONG NAIL WAS BROKEN THROUGH THE APERTURE FOR THE HELICAL BLADE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A LONG TFNA NAIL, HELICAL BLADE, TWO (2) LOCKING SCREWS, AND TWO (2) UNKNOWN CABLES BELOW THE LESSER TROCHANTER IN (B)(6) 2018, DUE TO A FRACTURE THAT WAS UNSTABLE HIGH SUBTROCHANTERIC WITH LESSER TROCHANTER ALSO FRACTURED OFF. ON (B)(6) 2018, THE PATIENT WAS REVISED WITH A 10 X 380MM ANTEGRADE FEMORAL NAIL (AFN), TWO (2) 2 X 6.5MM RECON SCREWS, AND A 1 X 4.9MM LOCKING BOLT DISTALLY IN THE DYNAMIC COMPONENT OF THE ELONGATED SLOT. THE IMPLANTED DEVICES WERE SUCCESSFULLY REMOVED WITHOUT ANY FRAGMENT GENERATED FROM THE BROKEN TFNA NAIL. PRIOR TO THE REVISION SURGERY, THE SURGEON DESCRIBED THAT THE PATIENT WAS BEING INVESTIGATED FOR STRESS FRACTURE IN THE CONTRA-LATERAL KNEE AND UNDERWENT A BONE SCAN. THIS BONE SCAN DEMONSTRATED A SIGNIFICANT "HOT SPOT" ON THE LEFT PROXIMAL FEMUR THAT WAS SUBSEQUENTLY INVESTIGATED INITIALLY BY PLAIN X-RAY THAT DEMONSTRATED THE DELAYED UNION OF THE SUBTROCHANTERIC FRACTURE AND THE BREAKAGE OF THE TFNA. THE PATIENT DID NOT DESCRIBE HAVING HAD A FALL OR DIFFICULTY WALKING (OTHER THAN PAIN IN THE OTHER KNEE) SO WAS MORE THAN LIKELY AMBULATING ON THE BROKEN TFNA FOR A PERIOD OF TIME WHICH MAY DESCRIBE WHY THE TFNA LONG NAIL HAD FRAGMENTED AROUND THE APERTURE. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME AFTER THE REVISION SURGERY WAS UNKNOWN BUT PATIENT WAS AMBULANT INDEPENDENTLY WITHOUT AID AND THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: 04.038.400S, LOT: H337958, QUANTITY: 1), LOCKING SCREW (PART: 04.005.526, LOT: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART: 04.005.538, LOT: UNKNOWN, QUANTITY: 1), CABLES (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995889 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H221492 07611819649859

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention