BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: DHS/DCS

    MDR report key: 14756413 · Received June 21, 2022

    Report

    Report Number
    8030965-2022-04181
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    January 1, 2016
    Report Date
    June 21, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE LOT NUMBER WAS UNKNOWN. THEREFORE, THE EXPIRATION DATE AND DEVICE MANUFACTURE DATE WERE UNKNOWN. 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. INVESTIGATION SUMMARY : PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 6 FOR PC-(B)(4). THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LIU S., XIA Y., KANG Y., WEI X., (2016) THE EFFECT COMPARISON BETWEEN TWO OPERATION METHODS FOR TREATMENT OF INTERTROCHANTERIC FRACTURES IN THE ELDERLY (CHINA). THIS STUDY AIMS TO INVESTIGATE THE EFFECT OF THE TWO KINDS OF INTERNAL FIXATION METHODS FOR TREATMENT OF INTERTROCHANTERIC FRACTURES IN THE ELDERLY. FROM MARCH 2011 TO MARCH 2016, 93 ELDERLY PATIENTS (38 MALES AND 55 FEMALES) AGED 60 TO 88 YEARS WITH INTERTROCHANTERIC FRACTURES WERE TREATED WITH SCREW-PLATE SYSTEM [FEMORAL LOCKING PLATE AND DYNAMIC HIP SCREW (DHS)] AND INTRAMEDULLARY FIXATION SYSTEM [FEMORAL ANTIROTATION INTRAMEDULLARY NAIL (PFNA)]. THE PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO DIFFERENT TREATMENT METHODS: SCREW-PLATE SYSTEM GROUP: 42 CASES, 15 MALES AND 27 FEMALES, AGED 60 ~ 79 (67.4 ± 5.5) YEARS. PFNA GROUP: 51 CASES, 23 MALES AND 28 FEMALES, AGED 65 ~ 88 (68.4 ± 3.6) YEARS. ALL PATIENTS WERE FOLLOWED UP FOR 6 TO 24 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: SCREW-PLATE SYSTEM GROUP: LIMB SHORTENING IN 7 CASES. HIP VARUS IN 7 CASES. DEEP VENOUS THROMBOSIS IN 1 CASE. HARRIS SCORES: 3 CASES WERE POOR. INTERNAL FIXATION FRACTURE IN 2 CASES. PLATE BREAKAGE RESULTED FROM AMBULATION WITH WEIGHT BEARING 2 MONTHS AFTER SURGERY. PFNA GROUP LIMB SHORTENING IN 2 CASES. HIP VARUS IN 1 . ARRIS SCORES: 2 CASES WERE POOR. THIS REPORT IS FOR UNKNOWN SYNTHES SCREW-PLATE SYSTEM [FEMORAL LOCKING PLATE AND DYNAMIC HIP SCREW (DHS)] AND UNKNOWN SYNTHES INTRAMEDULLARY FIXATION SYSTEM [FEMORAL ANTIROTATION INTRAMEDULLARY NAIL (PFNA)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546754 UNK - SCREWS: DHS/DCS SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention