BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 9712662 · Received February 14, 2020

    Report

    Report Number
    8030965-2020-01149
    Event Type
    Injury
    Date Received
    February 14, 2020
    Report Date
    February 4, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW/ 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KOSTIC, I., MITKOVIC, M., MITKOVIC, M. (2019), THE DIAPHYSEAL ASEPTIC TIBIAL NONUNIONS AFTER FAILED PREVIOUS TREATMENT OPTIONS MANAGED WITH THE REAMED INTRAMEDULLARY LOCKING NAIL, JOURNAL OF CLINICAL ORTHOPAEDICS AND TRAUMA, VOL. 10 (1), PAGES 182¿190 (SERBIA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO REPORT THE PRELIMINARY RESULTS OF THE TREATMENT OF ASEPTIC DIAPHYSEAL TIBIAL NONUNION WITH REAMED INTERLOCKED IM NAILING AFTER PREVIOUS FAILED TREATMENT CARE, WITH THE ABILITY TO PERFORM CORRECTION OF AXIS ALIGNMENT AND NEED FOR A SUPPLEMENTARY BONE GRAFTING USING THIS SURGICAL TECHNIQUE. BETWEEN 2008 TO 2014, A TOTAL OF 33 PATIENTS (21 MALE AND 12 FEMALE) WITH A MEAN AGE OF 39.4±15.7 YEARS (RANGE 18-63 YEARS) WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING EXPERT-TIBIAL NAIL (DEPUY SYNTHES, USA) AND A COMPETITOR DEVICE. OUTPATIENT FOLLOW-UP WAS SCHEDULED AT 6, 12 AND 24 WEEKS POSTOPERATIVELY WITH OUTCOME OF THE SURGICAL TREATMENT CLOSELY FOLLOWED-UP CLINICALLY AND RADIOLOGICALLY FOR A MINIMUM OF 12 MONTHS. FOLLOW-UP PERIOD WAS IN AVERAGE 24 MONTHS (RANGE 12 MONTHS TO 48 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN 2 CASES (6.06%) ANTERIOR BOWING OF 15% OCCURRED WITHOUT ANY FUNCTIONAL SIGNIFICANCE EXCEPT THAT THE COSMETICALLY WAS NOTICEABLE. IN 1 PATIENT (3.03%) POSTERIOR BOWING OF 10% OCCURRED, WHILE IN ANOTHER 2 CASES (6.06%) SHORTENING OF MORE THAN 15 MM REGISTERED AND NECESSITATE OF SHOE LIFT FOR LEG LENGTH EQUALIZATION WERE NEEDED. IN 4 PATIENTS, ADDITIONAL AUTOGENOUS BONE CHIPS WERE ADDED, WHERE CORTICAL DEFECT WAS GREATER THAN 50% OF THE BONE CIRCUMFERENCE. A (B)(6) YEAR-OLD MALE PATIENT HAD RADIOGRAPHIC SIGNS OF SEPTIC NONUNION SIX WEEKS POSTOPERATIVE. 1 PATIENT HAD RADIOGRAPHIC BREAKAGE OF THE TWO PROXIMAL AND TWO DISTAL LOCKING SCREWS AS WELL AS THE POOR CALLUS FORMATION, ACCOMPANIED BY PAINFUL WEIGHT-BEARING. IN 2 PATIENTS WITH PRIMARILY STATICALLY LOCKED INTRAMEDULLARY NAILS, A SCREW REMOVAL FOR DYNAMIZATION WAS PERFORMED AS AN OUTPATIENT PROCEDURE THREE MONTHS POSTOPERATIVELY, DUE TO POOR CALLUS FORMATION, UNDER LOCAL ANAESTHESIA, WHEN THE FARTHEST SCREW(S) FROM THE NONUNION SITE WERE REMOVED, AND PATIENTS WERE ALLOWED TO BEAR WEIGHT AS TOLERATED AT THE FIRST FOLLOW-UP VISIT. THIS REPORT IS FOR AN UNKNOWN SYNTHES LOCKING SCREW. IT CAPTURES THE REPORTED EVENT OF BREAKAGE OF THE DISTAL LOCKING SCREW AS WELL AS THE POOR CALLUS FORMATION, ACCOMPANIED BY PAINFUL WEIGHT BEARING. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174711 UNK - SCREWS: LOCKING SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention