BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING: CALCANEAL

    MDR report key: 11850821 · Received May 19, 2021

    Report

    Report Number
    8030965-2021-04042
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    April 21, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN LOCKING CALCANEAL SCREWS/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. 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: YIN, W. ET AL (2016), MINIMALLY INVASIVE REDUCTION OF THE MEDIAL WALL SHORTENING AND MISALIGNMENT IN CALCANEAL FRACTURES WITH INTRAOPERATIVE PERCUTANEOUS TRACTION USING AN EXTERNAL FIXATOR, INTERNATIONAL JOURNAL OF CLINICAL AND EXPERIMENTAL MEDICINE, VOL. 9 (9), PAGES 18033-18039 (CHINA). THE AIM OF THIS STUDY IS TO EVALUATE THE OUTCOMES OF THE APPLICATION OF INTRAOPERATIVE PERCUTANEOUS TRACTION USING AN EXTERNAL FIXATOR FOR THE REDUCTION OF MEDIAL WALL SHORTENING AND MISALIGNMENT IN CALCANEAL FRACTURES. BETWEEN DECEMBER 2011 TO DECEMBER 2013, A TOTAL OF 23 SANDERS TYPE III OR TYPE IV CALCANEAL FRACTURES WITH MEDIAL WALL SHORTENING AND MISALIGNMENT IN 22 PATIENTS (16 MALE AND 6 FEMALE) WITH A MEAN AGE OF 37 YEARS (RANGE, 30 TO 44 YEARS) WERE REDUCED WITH OPEN REDUCTION AND INTERNAL FIXATION COMBINED WITH INTRAOPERATIVE PERCUTANEOUS TRACTION. SURGERY WAS PERFORMED USING CALCANEAL PLATES AND SCREWS (DEPUY, WARSAW, IN, USA). THE MEAN FOLLOW-UP PERIOD WAS 13 MONTHS (RANGE, 6 MONTHS TO 2 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD A WOUND EDGE NECROSIS WHICH HEALED AT 20 DAYS AFTER SURGERY AND REQUIRED NO FURTHER INTERVENTION. THIS REPORT IS FOR UNKNOWN SYNTHES CALCANEAL LOCKING SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745362 UNK - SCREWS: LOCKING: CALCANEAL SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention