BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X46MM

    MDR report key: 16406647 · Received February 21, 2023

    Report

    Report Number
    0009613350-2023-00064
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 22, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505476
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN: JAPAN. CONCOMITANT MEDICAL PRODUCTS: PROXIMAL HUMERUS, RIGHT, 11X160MM ITEM#: 47249616011, LOT#: 3081920; BLUNT TIP SCREW, 4X46MM ITEM#: 47248604640, LOT#3076834; BLUNT TIP SCREW, 4X48MM ITEM#: 47248604840, LOT#3076790. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00061, 0009613350-2023-00063 AND 0009613350-2023-00065. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE SURGICAL TECHNIQUE EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." RADIOGRAPHS WERE PROVIDED AND REVIEWED FROM A RADIOLOGIST. TWO UNDATED X-RAYS OF THE RIGHT SHOULDER WERE PROVIDED. INITIAL IMAGE WITH SURGICAL STAPLES REVEALS ANATOMIC ALIGNMENT OF THE RIGHT PROXIMAL HUMERAL FRACTURE FIXATION WITH INTRAMEDULLARY NAIL, PLATE AND MULTIPLE SCREWS. THE SECOND IMAGE, FOLLOWING STAPLE REMOVAL, DEMONSTRATES MAINTAINED ALIGNMENT, ALTHOUGH ONE OF THE PROXIMAL SCREWS HAS SLIGHTLY RETRACTED SINCE THE PRIOR EXAM. IMPLANT FIT AND ALIGNMENT IS MAINTAINED ON BOTH IMAGES. BONE QUALITY IS OSTEOPENIC. NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, OR ANY OTHER CONTRIBUTING FACTOR SUCH AS MALALIGNMENT THAT WOULD CAUSE ISSUES WITH ANY OF THE COMPONENTS ON THE X-RAY. BASED ON THE INVESTIGATION, IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS CONTRIBUTING TO THE MIGRATION OF THE SCREWS COULD BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY THREE (3) MONTHS AFTER IMPLANTATION, DURING A ROUTINE POST-OPERATIVE CHECK-UP, IT WAS FOUND OUT THAT THE PROXIMAL SCREW HAD BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944781 BLUNT TIP SCREW, 4X46MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3081981 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Other SEEH10NARRATIVE