BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS

    MDR report key: 11366076 · Received February 23, 2021

    Report

    Report Number
    8030965-2021-01255
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    November 5, 2019
    Report Date
    February 2, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: HAO Y., ET AL (2020)PREDICTORS AND REDUCTION TECHNIQUES FOR IRREDUCIBLE REVERSE INTERTROCHANTERIC FRACTURES,CHINESE MEDICAL JOURNAL VOLUME 132(21), PAGES 2534-2542 (CHINA)DOI:10.1097/CM9.0000000000000493. THIS RETROSPECTIVE STUDY AIMS TO HELP SURGEONS RECOGNIZE IRREDUCIBLE FRACTURES PREOPERATIVELY AND PROVIDE SOME REDUCTION TECHNIQUES FOR DIFFERENT DISPLACEMENT PATTERNS. BETWEEN JANUARY 2006 AND OCTOBER 2018 , 113 ADULT PATIENTS (48 MALES, 65 FEMALES) WITH AN AVERAGE AGE OF 73.9 YEARS (37¿92 YEARS) WHO UNDERWENT SURGERY FOR REVERSE INTERTROCHANTERIC FRACTURES MET THE INCLUSION CRITERION FOR THE STUDY. ACCORDING TO THE REDUCTION QUALITY OF FRACTURES AFTER CLOSED MANIPULATION, THE PATIENTS WERE DIVIDED INTO REDUCIBLE GROUP WITH 37 PATIENTS (14 MALES,23 FEMALES) AND IRREDUCIBLE GROUPS WITH 76 PATIENTS (34 MALES, 42 FEMALES). REDUCTION AND INTERNAL FIXATION WERE PERFORMED USING EXTRAMEDULLARY 28 CONTRALATERAL DISTAL FEMORAL LOCKING PLATE (LISS; SYNTHES USA, PAOLI, PA) ; 6 PERIARTICULAR PROXIMAL FEMORAL LOCKING PLATES (PERI-LOC®PFP; SMITH & NEPHEW, INC., MEMPHIS, TN, USA); 1 DYNAMIC HIP SCREW (DHS; SYNTHES USA, PAOLI, PA)AND TROCHANTERIC STABILIZING PLATE (TSP; SYNTHES USA, PAOLI, PA); 1 DYNAMIC HIP SCREW (DHS; SYNTHES USA, PAOLI, PA) AND ANTI-ROTATION SCREW (SYNTHES USA, PAOLI, PA)OR INTRA-MEDULLARY DEVICES: 32 PROXIMAL FEMORAL NAIL ANTI-ROTATION-II (PFNAII; SYNTHES USA, PAOLI, PA); 6 TRIGEN INTERTAN NAIL (SMITH & NEPHEW, INC.; MEMPHIS, USA); 4 GAMMA 3 (STRYKER, MAHWAH, NJ, USA); 4 PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA; SYNTHES USA, PAOLI, PA); 2TRIGEN TAN NAIL (SMITH & NEPHEW, INC.; MEMPHIS, TN, USA).THE MEAN FOLLOW-UP TIME WAS 24.3 MONTHS (RANGE, 3¿75 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GOOD REDUCTION QUALITY AFTER USING REDUCTION TECHNIQUES IS ONLY 53, ACCEPTABLE REDUCTION QUALITY AFTER USING REDUCTION TECHNIQUES IS ONLY 15. EIGHT CASES WITH POOR REDUCTION QUALITY. ONE CASE OF HELICAL BLADE CUT-OUT, IMPLANT FAILURE OCCURRED (OF THE 53 CASES WITH GOOD REDUCTION QUALITY). ONE CASE OF HELICAL BLADE PERFORATION, IMPLANT FAILURE OCCURRED (OF THE 53 CASES WITH GOOD REDUCTION QUALITY). ONE CASE OF HELICAL BLADE CUT-OUT,IMPLANT FAILURE OCCURRED (OF THE 15 CASES WITH ACCEPTABLE REDUCTION QUALITY). ONE CASE OF HELICAL BLADE CUTOUT IMPLANT FAILURE OCCURRED(OF THE EIGHT CASES WITH POOR REDUCTION QUALITY). TWO CASES OF SCREW BREAKAGE, IMPLANT FAILURE OCCURRED (OF THE 53 CASES WITH GOOD REDUCTION QUALITY). ONE CASE OF MAIN NAIL BREAKAGE OCCURRED, IMPLANT FAILURE OCCURRED (OF THE 53 CASES WITH GOOD REDUCTION QUALITY). ONE CASE OF SCREW BREAKAGE OCCURRED, IMPLANT FAILURE OCCURRED (OF THE 15 CASES WITH ACCEPTABLE REDUCTION QUALITY). ONE CASE OF SCREW BREAKAGE IMPLANT FAILURE OCCURRED(OF THE EIGHT CASES WITH POOR REDUCTION QUALITY). ONE CASE OF MAIN NAIL BREAKAGE OCCURRED, IMPLANT FAILURE OCCURRED(OF THE EIGHT CASES WITH POOR REDUCTION QUALITY). (ARTICLE DID NOT SPECIFY WHICH DEVICE IS INVOLVED FOR THE FOLLOWING ALLEGATIONS CAPTURED). THIS REPORT IS FOR AN UNKNOWN SYNTHES CONTRALATERAL DISTAL FEMORAL LOCKING PLATE (LISS); UNKNOWN SYNTHES DYNAMIC HIP SCREW (DHS); UNKNOWN SYNTHES TROCHANTERIC STABILIZING PLATE (TSP); UNKNOWN SYNTHES ANTI-ROTATION SCREW; UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTI-ROTATION-II (PFNAII); AND UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262278 UNK - NAILS NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention