BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 11983443 · Received June 11, 2021

    Report

    Report Number
    8030965-2021-04820
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    November 1, 2005
    Report Date
    June 2, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS 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. 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: HOFSTAETTER S.G., ET AL (2005) THE WEIL OSTEOTOMY A SEVEN-YEAR FOLLOW-UP, J BONE JOINT SURG VOLUME 87-B, NO. 11, PAGES 1507-1511 (AUSTRIA) DOI:10.1302/0301-620X.87B11. THIS PROSPECTIVE STUDY AIMS TO EVALUATE THE CLINICAL AND RADIOLOGICAL ASSESSMENT WITH SPECIAL ATTENTION TO RECURRENT PAIN, THE DISLOCATION RATE OF THE MTP JOINT, TOE GROUND CONTACT AND PATIENT SATISFACTION WITH A SEVEN-YEAR FOLLOW- UP OF THE WEIL OSTEOTOMY, FOR THE TREATMENT OF A PAINFUL SUBLUXED OR DISLOCATED MTP JOINT. BETWEEN 1995 AND 1996, 31 PATIENTS UNDERWENT A WEIL OSTEOTOMY FOR THE TREATMENT OF A PAINFUL SUBLUXATION OR DISLOCATION OF THE MTP JOINT OR EXCESSIVE LENGTH OF THE SECOND METATARSAL (ABNORMAL METATARSAL PARABOLA) WITH AN INTRACTABLE PAINFUL PLANTAR CALLOSITY. 25 FEET IN 24 PATIENTS WERE FOLLOWED UP, TWO MEN AND 22 WOMEN WITH A MEAN AGE AT THE TIME OF SURGERY OF 60 YEARS (46 TO 77) FOR SEVEN YEARS. FIXATION WAS DONE USING A 2-MM TITANIUM TWIST-OFF SCREW (DEPUY; JOHNSON & JOHNSON, VIENNA, AUSTRIA). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TWO DIED FROM UNRELATED CAUSES.(EXCLUDED FROM STUDY). FAIR RESULTS WERE REPORTED IN TWO FEET AT ONE YEAR AS WELL AS AT SEVEN YEARS. AFTER ONE YEAR TWO FEET WERE RATED AS POOR AND ONLY ONE AFTER SEVEN YEARS. PATIENTS WITH FAIR AND POOR RESULTS MAIN COMPLAINT WAS FLOATING, THAT IS TOES WHICH DID NOT TOUCH THE GROUND, AND STIFF TOES. FIVE PATIENTS HAD A POORER RESULT AT SEVEN YEARS THAN AT ONE YEAR. THE MAJOR COMPLAINT OF THE UNSATISFIED PATIENT AT ONE AND SEVEN YEARS POST-OPERATIVELY WAS PAIN. SIX CAUSED MILD, TWO CAUSED MODERATE AND NONE CAUSED SEVERE PAIN. ONE YEAR AFTER SURGERY, SEVEN CAUSED MILD PAIN, TWO MODERATE PAIN AND THREE SEVERE PAIN. INADEQUATE SHORTENING CAUSED RECURRENT PAINFUL CALLUS FORMATION IN THE OTHER TWO PATIENTS AFTER SEVEN YEARS. PAINFUL CALLUS FORMATION UNDER THE METATARSAL HEAD WAS SEEN IN SIX AT ONE YEAR AND THREE AT SEVEN YEARS. SEVEN YEARS AFTER SURGERY, HAD MODERATE RESTRICTION (30° TO 75°), AND 11 (20%) HAD SEVERE RESTRICTION (< 30°) OF MOVEMENT OF THE MTP JOINT. DORSAL MTP DISLOCATIONS IN TWO AFTER ONE YEAR AND THREE (12%) AFTER SEVEN YEARS. ONE PATIENT WITH A DISLOCATED, PAINFUL MTP JOINT UNDERWENT A REVISION WEIL OSTEOTOMY. THE RADIOGRAPH OF AN UNSATISFIED PATIENT AT ONE YEAR REVEALED A PROMINENT SCREW TIP THAT HAD PENETRATED THE PLANTAR SIDE OF THE FOOT. THE PATIENT WAS COMFORTABLE AFTER REMOVAL OF THE SCREW. THIS REPORT IS FOR AN UNKNOWN SYNTHES 2-MM TITANIUM TWIST-OFF SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878207 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1