BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: PHILOS

    MDR report key: 11959642 · Received June 8, 2021

    Report

    Report Number
    8030965-2021-04670
    Event Type
    Injury
    Date Received
    June 8, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PHILOS 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. 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: SEO, J.-B., YOO, J.-S., KIM, Y.-J., AND KIM, K.-B. (2020), ASSESSMENT OF THE EFFICACY OF THE FAR CORTICAL LOCKING TECHNIQUE IN PROXIMAL HUMERAL FRACTURES: A COMPARISON WITH THE CONVENTIONAL BI-CORTICAL LOCKING TECHNIQUE, BMC MUSCULOSKELETAL DISORDERS, VOL. 21 (800), PAGES 1-8 (KOREA, SOUTH). THE AIM OF THIS NON-RANDOMIZED RETROSPECTIVE STUDY IS TO ANALYZE AND COMPARE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF THE FCL AND BCL PROCEDURES IN PROXIMAL HUMERAL FRACTURES. BETWEEN JANUARY 2013 TO MAY 2018, A TOTAL OF 45 PATIENTS (20 MALE AND 25 FEMALE) WITH AN AGE RANGE OF 18¿84 YEARS UNDERWENT LOCKING FIXATION. SURGERY WAS PERFORMED USING A PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE (DEPUY SYNTHES, ZUCHWIL, SWITZERLAND) WITH ONE 3.5-MM CORTICAL SCREW AND TWO OR THREE BCL SCREWS IN 27 PATIENTS (BCL GROUP; 12 MALE AND 15 FEMALE; MEAN AGE = 53.0 ± 12.4 YEARS). THE FCL GROUP WAS PERFORMED USING A COMPETITOR DEVICE. THE MEAN FOLLOW-UP PERIOD WAS 15.9 ± 6.0 MONTHS AND 12.7 ± 1.9 MONTHS FOR BCL AND FCL GROUP, RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD DELAYED UNION. 6 PATIENTS HAD STIFFNESS AT 1 YEAR AFTER SURGERY, AND A SINGLE PATIENT (UNKNOWN GROUP) UNDERWENT BRISEMENT CONCOMITANTLY WITH PLATE REMOVAL. 2 PATIENTS HAD RESORPTION OR MIGRATION OF THE GREATER TUBEROSITY. 1 PATIENT HAD AVASCULAR NECROSIS OF HUMERAL HEAD WITH SCREW PENETRATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES PHILOS SCREW. IT CAPTURES THE REPORTED AVASCULAR NECROSIS WITH SCREW PENETRATION. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857130 UNK - SCREWS: PHILOS SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention