BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: 6.5 MM CANNULATED SCREW/WASHER

    MDR report key: 15076495 · Received July 21, 2022

    Report

    Report Number
    2939274-2022-02801
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    February 16, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN SCREWS: 6.5 MM CANNULATED/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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HSU M., ET AL (2022) IS THERE AN INCREASED RISK FOR SUBTROCHANTERIC STRESS FRACTURE WITH THE FEMORAL NECK SYSTEM VERSUS MULTIPLE CANNULATED SCREWS FIXATION?, JOURNAL OF ORTHOPAEDICS VOLUME, PAGES 30 127¿133 (USA). THIS STUDY AIMS TO COMPARE THE RISK OF IATROGENIC SUBTROCHANTERIC STRESS-RISER FRACTURES CAUSED BY THE FEMORAL NECK SYSTEM (FNS)VERSUS MULTIPLE SCREW FIXATION (MSF) IN AN ELDERLY CADAVERIC FEMUR MODEL. IN THE D STUDY, EIGHT PAIRED FRESH-FROZEN HUMAN CADAVERIC FEMURS AGED OVER 60 YEARS WERE OBTAINED. RADIOGRAPHS WERE USED TO EXCLUDE SPECIMENS WITH KELLGREN-LAWRENCE GRADE 3¿4 OSTEOARTHRITIS, NECK-SHAFT ANGLE LESS THAN 120 OR GREATER THAN 135, AND PREVIOUS HIP FRACTURE OR IMPLANTS. EACH SIDE OF THE PAIRED SPECIMENS WERE RANDOMLY ASSIGNED TO FNS OR MSF. FEMURS WERE THEN THAWED FOR 24 H, STRIPPED OF ANY SOFT TISSUE, AND IMPLANTED WITH EITHER FNS ONE-HOLE 130-DEGREE SIDE PLATE (FNS, DEPUY SYNTHES, WEST CHESTER, PA) OR 6.5 MM SELF-TAPPING, PARTIALLY THREADED CANNULATED STAINLESS-STEEL SCREWS WITH 16 MM THREADS (CANNULATED SCREW SYSTEM, DEPUY SYNTHES, WEST CHESTER, PA). ALL CANNULATED SCREWS WERE PLACED WITH WASHERS AND IN THE STANDARD INVERTED TRIANGLE CONFIGURATION. REPORTED COMPLICATIONS INCLUDED: TWO CASE EXAMPLES: AN 88-YEAR-OLD FEMALE WITH A STABLE, MINIMALLY DISPLACED INTERTROCHANTERIC FRACTURE WAS TREATED AT A REFERRING FACILITY WITH THE FNS (FIG. 1). SHE DID WELL UNTIL ONE MONTH POSTOPERATIVELY WHEN SHE FELL WHILE STANDING AND SUSTAINED A PERI-IMPLANT SUBTROCHANTERIC FRACTURE (FIG. 2). A 35-YEAR-OLD FEMALE WHO SUSTAINED A FEMORAL NECK FRACTURE AFTER A GROUND LLLEVEL FALL AND WAS APPROPRIATELY TREATED WITH THE FNS. SHE RETURNED WITH A RIGHT PERI-IMPLANT SUBTROCHANTERIC FEMUR FRACTURE 1 MONTH LATER AFTER A FALL FROM STANDING (FIG. 3). HUMAN CADAVERIC FEMURS: MSF CONSTRUCTS: ALL SPECIMENS FAILED BY FRACTURE THROUGH BONE. THERE WAS NO EVIDENCE OF IMPLANT BENDING OR BREAKAGE ON ANY POST-FAILURE RADIOGRAPHS. THE MSF CONSTRUCTS TENDED TO FAIL JUST DISTAL TO THE TWO PROXIMAL SCREWS IN THE INVERTED TRIANGLE. (SPECIMEN PAIR 1) FRACTURE BELOW THE TWO TOP SCREWS AND ABOVE THE BOTTOM SCREW. (SPECIMEN PAIR 2) FEMORAL HEAD SUBSIDED. (SPECIMEN PAIR 3) FRACTURE ON THE SHAFT AT THE LEVEL OF THE TWO TOP SCREWS. (SPECIMEN PAIR 4) FRACTURE BELOW THE TWO TOP SCREWS AND ABOVE THE BOTTOM SCREW. (SPECIMEN PAIR 6) FRACTURE BELOW THE TWO TOP SCREWS AND ABOVE THE BOTTOM SCREW. (SPECIMEN PAIR 7) FRACTURE BELOW THE TWO TOP SCREWS AND ABOVE THE BOTTOM SCREW. (SPECIMEN PAIR 8) FRACTURE BELOW THE TWO TOP SCREWS AND ABOVE THE BOTTOM SCREW. FNS CONSTRUCTS: ALL SPECIMENS FAILED BY FRACTURE THROUGH BONE. THERE WAS NO EVIDENCE OF IMPLANT BENDING OR BREAKAGE ON ANY POST-FAILURE RADIOGRAPHS. ALL BUT ONE OF THE FNS CONSTRUCTS FAILED THROUGH THE REAMER HOLE FOR THE FNS BOLT. (SPECIMEN PAIR 1) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. (SPECIMEN PAIR 2) FEMORAL HEAD SUBSIDED. (SPECIMEN PAIR 3) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. (SPECIMEN PAIR 4) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. (SPECIMEN PAIR 5) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. (SPECIMEN PAIR 6) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. (SPECIMEN PAIR 7) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. (SPECIMEN PAIR 8) SPECIMEN BROKE ON THE SUPERIOR SIDE OF THE PLATE AT THE LEVEL OF THE CENTER BOLT. THIS REPORT IS FOR UNKNOWN SYNTHES FNS ONE-HOLE 130-DEGREE SIDE PLATE AND AN UNKNOWN PARTIALLY THREADED CANNULATED STAINLESS-STEEL SCREWS WITH 16 MM THREADS (CANNULATED SCREW SYSTEM). THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262053 UNK - CONSTRUCTS: 6.5 MM CANNULATED SCREW/WASHER SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention