BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TOMOFIX

    MDR report key: 12558106 · Received September 30, 2021

    Report

    Report Number
    8030965-2021-08187
    Event Type
    Injury
    Date Received
    September 30, 2021
    Report Date
    September 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TOMOFIX SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. (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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RUPP M.C., ET AL (2021) : DISLOCATED HINGE FRACTURES ARE ASSOCIATED WITH MALUNION AFTER LATERAL CLOSING WEDGE DISTAL FEMORAL OSTEOTOMY, KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY XXXX, PAGES 1-11 (GERMANY). THIS STUDY AIMS TO EVALUATE THE INCIDENCE, MORPHOLOGY, AND ASSOCIATED COMPLICATIONS OF MEDIAL CORTICAL HINGE FRACTURES AFTER LCW-DFO. BETWEEN JANUARY 2007 AND MARCH 2018, A TOTAL OF 79 PATIENTS (MEAN AGE: 47 ± 12 YEARS, 27 FEMALES, 52 MALES) WHO UNDERWENT LATERAL CLOSING WEDGE -DISTAL FEMORAL OSTEOTOMY (LCW-DFO) FOR SYMPTOMATIC VARUS MALALIGNMENT WERE INCLUDED IN THE FINAL ANALYSIS. A LOCKING COMPRESSION PLATE - EITHER PEEK-POWER¿ PLATE (ARTHREX INC., NAPLES, FL, USA) OR TOMOFIX¿ PLATE (DEPUY SYNTHES, RAYNHAM, MA, USA)¿WAS USED TO SECURE THE OSTEOTOMY. PATIENTS WERE ROUTINELY FOLLOWED UP IN AMBULATORY CARE AT THE AUTHORS¿ INSTITUTION AT 6 WEEKS, 12 WEEKS AND 1 YEAR POSTOPERATIVELY AND STANDARD RADIOGRAPHS WERE OBTAINED TO EVALUATE CONSOLIDATION OF THE OSTEOTOMY PLANE. THE FOLLOWING COMPLICATIONS WERE REPORTED: MEDIAL CORTICAL HINGE FRACTURE WAS DETECTED IN 38 OF THE CASES (10 FEMALES, 28 MALES). COMPLICATIONS OCCURRED IN 7 OF THE CASES. THE INCIDENCE OF MALUNIONS DURING FOLLOW-UP WAS 6 ACROSS THE ENTIRE PATIENT COLLECTIVE. THESE MALUNIONS TENDED TO OCCUR MORE FREQUENTLY IN THE CASES WITH A CONCOMITANT MEDIAL CORTICAL HINGE FRACTURE (N=5) WHERE 3 PATIENTS WERE IMPLANTED WITH TOMOFIX¿. A MEDIOLATERAL DISLOCATION OF THE MEDIAL CORTICAL BONE > 2 MM IN THE CORONAL PLANE COULD BE DETECTED IN 5 (100%) OF THE CASES WITH MALUNION. MEDIOLATERAL DISLOCATION AFTER MEDIAL CORTICAL HINGE FRACTURE. A STANDARD AP RADIOGRAPH TAKEN ON THE FIRST POSTOPERATIVE DAY AFTER BIPLANE LCW-DFO USING A TOMOFIX¿ LOCKING COMPRESSION PLATE IS SHOWING A MEDIOLATERAL DISLOCATION OF > 2 MM IN THE CORONAL PLANE OF THE MEDIAL CORTICAL BONE CAUSED BY A MEDIAL CORTICAL HINGE FRACTURE. 1 BLEEEDING WITH HINGE FRACTURE, 1 DELAYED UNION, WITH HINGE FRACTURES, 4 NON-UNION WITH HINGE FRACTURE, 1 NON-UNION, 2 LOSS OF CORRECTION, 2 SCREW LOOSENING, WITH HINGE FRACTURE. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX¿ PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451595 UNK - SCREWS: TOMOFIX SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention